Prescription Drug Information: Doxycycline Hyclate (Page 3 of 3)

HOW SUPPLIED

Doxycycline Hyclate Capsules, USP 50 mg are available as a blue and white capsule filled with yellow powder, imprinted with “2984”, containing doxycycline hyclate equivalent to 50 mg doxycycline.

NDC 47781-489-50 Bottles of 50 capsules

Doxycycline Hyclate Capsules, USP 100 mg are available as a light blue capsule filled with yellow powder, imprinted with “2985”, containing doxycycline hyclate equivalent to 100 mg doxycycline.

NDC 47781-490-50 Bottles of 50 capsules
NDC 47781-490-05 Bottles of 500 capsules

Doxycycline Hyclate Tablets, USP 100 mg are available as a round, orange film-coated tablet engraved with “3626” on one side, and plain on the other side, containing doxycycline hyclate equivalent to 100 mg doxycycline.

NDC 47781-491-50 Bottles of 50 tablets
NDC 47781-491-05 Bottles of 500 tablets

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO₄ , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO₄ , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO₄ , methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

REFERENCES

1. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149-195.

2. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524-528.

3. Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315-317.

4. Hale T. Medications and Mothers Milk. 9^th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225-226.

For more information, please call Alvogen, Inc. at 1-866-770-3024.

Brands listed are the trademarks of their respective owners.

Manufactured By:
Chartwell Pharmaceuticals, LLC
Congers, NY 10920 USA

Distributed By:
Alvogen, Inc.
Pine Brook, NJ 07058 USA

PI489-02
Rev. 12/2018

NDC 47781-489 -50
DOXYCYCLINE
HYCLATE
Capsules USP

50 mg*

*Each capsule contains:
doxycycline hyclate equivalent to 50 mg doxycycline.

50 CAPSULES Rx only

Alvogen^®

NDC 47781-490 -50
DOXYCYCLINE
HYCLATE
Capsules USP

100 mg*

*Each capsule contains:
doxycycline hyclate equivalent to 100 mg doxycycline.

50 CAPSULES Rx only

Alvogen^®

NDC 47781-491 -50
DOXYCYCLINE
HYCLATE
Tablets USP

100 mg*
*Each tablet contains:
doxycycline hyclate equivilent to 100 mg doxycycline.

50 TABLETS Rx only

Alvogen^®

DOXYCYCLINE HYCLATE doxycycline hyclate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-489 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Doxycycline Hyclate (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 50 mg

Inactive Ingredients Ingredient Name Strength Silicon Dioxide Anhydrous Lactose Magnesium Stearate Methylcellulose (1500 Mpa.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED Stearic Acid FD&C BLUE NO. 1 D&C YELLOW NO. 10 Sodium Starch Glycolate Type A Potato GELATIN, UNSPECIFIED TITANIUM DIOXIDE BUTYL ALCOHOL ALCOHOL FD&C BLUE NO. 2 FD&C RED NO. 40 FERROSOFERRIC OXIDE PROPYLENE GLYCOL SHELLAC

Product Characteristics Color BLUE, WHITE Score no score Shape CAPSULE Size 17mm Flavor Imprint Code 2984 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:47781-489-50 50 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062500 06/27/2016 05/01/2021

DOXYCYCLINE HYCLATE doxycycline hyclate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-490 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Doxycycline Hyclate (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg

Inactive Ingredients Ingredient Name Strength Silicon Dioxide Anhydrous Lactose Magnesium Stearate Methylcellulose (1500 Mpa.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED Stearic Acid FD&C BLUE NO. 1 Sodium Starch Glycolate Type A Potato GELATIN, UNSPECIFIED TITANIUM DIOXIDE ALCOHOL BUTYL ALCOHOL D&C YELLOW NO. 10 FD&C BLUE NO. 2 FD&C RED NO. 40 FERROSOFERRIC OXIDE PROPYLENE GLYCOL SHELLAC

Product Characteristics Color BLUE (light blue ) Score no score Shape CAPSULE Size 21mm Flavor Imprint Code 2985 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:47781-490-50 50 CAPSULE in 1 BOTTLE None 2 NDC:47781-490-05 500 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062500 06/27/2016 10/01/2021

DOXYCYCLINE HYCLATE doxycycline hyclate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-491 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Doxycycline Hyclate (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg

Inactive Ingredients Ingredient Name Strength Silicon Dioxide Anhydrous Lactose Magnesium Stearate HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED Stearic Acid Titanium Dioxide FD&C RED NO. 40 FD&C YELLOW NO. 6 METHYLCELLULOSE (1500 MPA.S) Sodium Starch Glycolate Type A Potato

Product Characteristics Color ORANGE Score no score Shape ROUND Size 9mm Flavor Imprint Code 3626 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:47781-491-50 50 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:47781-491-05 500 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062505 07/19/2016 05/01/2023

Labeler — Alvogen, Inc. (008057330)

Revised: 09/2019 Alvogen, Inc.