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

HOW SUPPLIED

Doxycycline hyclate tablets USP, 100 mg are available in light orange colored, round shape, biconvex, film-coated tablets debossed with “141” on one side and “L” on other side containing doxycycline hyclate equivalent to 100 mg doxycycline

NDC 62332-353-20 Bottle of 20 tablets

NDC 62332-353-50 Bottle of 50 tablets

NDC 62332-353-71 Bottle of 500 tablets

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

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.

For more information call Alembic Pharmaceuticals Limited at 1-866-210-9797.

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.

Manufactured by:

Alembic Pharmaceuticals Limited

(Formulation Division),

Panelav 389350, Gujarat, India

Manufactured for:

Alembic Pharmaceuticals, Inc.

750 Route 202, Bridgewater, NJ 08807

USA

Revised: 01/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62332-353-20
Doxycycline Hyclate
Tablets, USP
100 mg*
Rx only
20 Tablets
Alembic

20's bottle pack
(click image for full-size original)
DOXYCYCLINE HYCLATE
doxycycline hyclate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-353
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
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
HYDROXYPROPYL CELLULOSE (70000 WAMW)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (light orange) Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code 141;L
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-353-20 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62332-353-50 50 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:62332-353-71 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210536 05/15/2020
Labeler — Alembic Pharmaceuticals Inc. (079288842)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (62332-353)

Revised: 05/2020 Alembic Pharmaceuticals Inc.

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