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

HOW SUPPLIED

Product: 50090-4592

NDC: 50090-4592-0 40 CAPSULE in a BOTTLE

NDC: 50090-4592-1 20 CAPSULE in a BOTTLE

NDC: 50090-4592-2 10 CAPSULE in a BOTTLE

NDC: 50090-4592-3 12 CAPSULE in a BOTTLE

NDC: 50090-4592-4 4 CAPSULE in a BOTTLE

NDC: 50090-4592-5 5 CAPSULE in a BOTTLE

NDC: 50090-4592-6 14 CAPSULE in a BOTTLE

NDC: 50090-4592-7 11 CAPSULE in a BOTTLE

NDC: 50090-4592-8 500 CAPSULE in a BOTTLE

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. 9th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225–226.

This product’s label may have been updated. For current full prescribing information, please visit www.amneal.com

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382220, INDIA

Distributed by:
Amneal Pharmaceuticals LLC Bridgewater, NJ 08807

Rev. 01-2019-04

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP.

Doxycycline

Label ImageLabel Image
DOXYCYCLINE HYCLATE doxycycline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4592(NDC:69238-1100)
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color BLUE (light blue opaque cap) , BLUE (light blue opaque body) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code AMNEAL;1100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4592-0 40 CAPSULE in 1 BOTTLE None
2 NDC:50090-4592-1 20 CAPSULE in 1 BOTTLE None
3 NDC:50090-4592-2 10 CAPSULE in 1 BOTTLE None
4 NDC:50090-4592-3 12 CAPSULE in 1 BOTTLE None
5 NDC:50090-4592-4 4 CAPSULE in 1 BOTTLE None
6 NDC:50090-4592-5 5 CAPSULE in 1 BOTTLE None
7 NDC:50090-4592-6 14 CAPSULE in 1 BOTTLE None
8 NDC:50090-4592-7 11 CAPSULE in 1 BOTTLE None
9 NDC:50090-4592-8 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207289 06/28/2016
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4592), REPACK (50090-4592)

Revised: 11/2019 A-S Medication Solutions

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