Demeclocycline Hydrochloride (Page 4 of 4)

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals LLC as follows:
(150 mg / 100 UD) NDC 62584-159-01 packaged from NDC 65162-554
(300 mg / 50 UD) NDC 62584-163-65 packaged from NDC 65162-555

Distributed by:
American Health Packaging Columbus, OH 43217

8015901/0419

Package/Label Display Panel – Carton – 150 mg

150 mg Demeclocycline HCl Tablets Carton
(click image for full-size original)

NDC 62584- 159 -01

Demeclocycline
Hydrochloride
Tablets, USP

150 mg

100 Tablets (10 x 10)               Rx Only

Each Film-Coated Tablet Contains:
Demeclocycline Hydrochloride, USP …………………………… 150 mg

Usual Dosage: See package insert for full prescribing
information.

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].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 65162-554, Amneal Pharmaceuticals LLC.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

015901 0015901/0419

Package/Label Display Panel — Blister— 150 mg

150 mg Demeclocycline HCl Tablet Blister
(click image for full-size original)

Demeclocycline Hydrochloride Tablet, USP

150 mg

Package/Label Display Panel — Carton — 300 mg

300 mg Demeclocycline HCl Tablets Carton
(click image for full-size original)

NDC 62584- 163 -65

Demeclocycline
Hydrochloride
Tablets, USP

300 mg

50 Tablets (5 x 10)               Rx Only

Each Film-Coated Tablet Contains:
Demeclocycline Hydrochloride, USP ………………………….. 300 mg

Usual Dosage: See package insert for full prescribing
information.

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].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 65162-555, Amneal Pharmaceuticals.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

016365 0016265/0419

Package/Label Display Panel — Blister — 300 mg

300 mg Demeclocycline HCl Tablet Blister
(click image for full-size original)

Demeclocycline Hydrochloride Tablet, USP

300 mg

DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62584-159(NDC:65162-554)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) DEMECLOCYCLINE HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID
STARCH, CORN
ETHYLCELLULOSE, UNSPECIFIED
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
D&C RED NO. 27
Product Characteristics
Color red Score no score
Shape ROUND Size 9mm
Flavor Imprint Code AN;54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62584-159-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (62584-159-11)
1 NDC:62584-159-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (62584-159-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065425 11/24/2010 07/31/2023
DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62584-163(NDC:65162-555)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) DEMECLOCYCLINE HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID
STARCH, CORN
ETHYLCELLULOSE, UNSPECIFIED
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color red Score no score
Shape ROUND Size 20mm
Flavor Imprint Code AN;55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62584-163-65 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (62584-163-11)
1 NDC:62584-163-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (62584-163-65)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065425 12/09/2010
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (62584-159), repack (62584-163)

Revised: 09/2022 American Health Packaging

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.