Acarbose: Package Insert and Label Information (Page 3 of 3)

HOW SUPPLIED

Acarbose Tablets, USP are supplied as follows:

For 25 mg: White to off white, round, biconvex tablets, debossed with “HP” on one side and “147” on other side.

For 50 mg: White to off white, round, biconvex tablets, debossed with “HP” and “148” on one side and plain on other side.

For 100 mg: White to off white, round, biconvex tablets, debossed with “HP” and “149” on one side and plain on other side.

Acarbose Tablets, USP 25 mg/50 mg/100 mg are available in Bottles of 100, 500 & 1,000.

	Strength	NDC	Table t Identificatio n
Bottles of 100 with child-resistance closure Bottles of 500 with child-resistance closure Bottles of 1,000 with child-resistance closure	25 mg 25 mg 25 mg	23155-147-01 23155-147-05 23155-147-10	“HP” on one side and “147” on other side.
Bottles of 100 with child-resistance closure Bottles of 500 with child-resistance closure Bottles of 1,000 with child-resistance closure	50 mg 50 mg 50 mg	23155-148-01 23155-148-05 23155-148-10	“HP” and “148” on one side and plain on other side.
Bottles of 100 with child-resistance closure Bottles of 500 with child-resistance closure Bottles of 1,000 with child-resistance closure	100 mg 100 mg 100 mg	23155-149-01 23155-149-05 23155-149-10	“HP” and “149” on one side and plain on other side.

Store at 20^o to 25^o C (68^o to 77^o F) [see USP Controlled Room Temperature]. Protect from moisture. For bottles, keep container tightly closed.

Manufactured by:

RA CHEM PHARMA LIMITED

Hyderabad – 500 076, INDIA

Distributed by:

Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816

1.866.901.DRUG (3784)

Revised: 01/2020

OR

Distributed by:
Avet Pharmaceuticals Inc.
East Brunswick, NJ 088161.866.901.DRUG(3784)

40211

Revised: 06/2022

PACKAGE LABEL PRINCIPAL DISPLAY PANEL (25mg)

NDC 23155-147 -01

Acarbose Tablets, USP

25 mg

100 Tablets

Rx only

PACKAGE LABEL PRINCIPAL DISPLAY PANEL (50mg)

NDC 23155-148 -01

Acarbose Tablets, USP

50 mg

100 Tablets

Rx only

PACKAGE LABEL PRINCIPAL DISPLAY PANEL (100mg)

NDC 23155-149 -01

Acarbose Tablets, USP

100 mg

100 Tablets

Rx only

ACARBOSE acarbose tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-147 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACARBOSE (ACARBOSE) ACARBOSE 25 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE MAGNESIUM STEARATE

Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-147-05 500 TABLET in 1 BOTTLE None 2 NDC:23155-147-01 100 TABLET in 1 BOTTLE None 3 NDC:23155-147-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202271 04/16/2021

ACARBOSE acarbose tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-148 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACARBOSE (ACARBOSE) ACARBOSE 50 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE MAGNESIUM STEARATE

Product Characteristics Color WHITE Score no score Shape ROUND Size 7mm Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-148-05 500 TABLET in 1 BOTTLE None 2 NDC:23155-148-01 100 TABLET in 1 BOTTLE None 3 NDC:23155-148-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202271 04/16/2021

ACARBOSE acarbose tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-149 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACARBOSE (ACARBOSE) ACARBOSE 100 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE MAGNESIUM STEARATE

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23155-149-01 100 TABLET in 1 BOTTLE None 2 NDC:23155-149-05 500 TABLET in 1 BOTTLE None 3 NDC:23155-149-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202271 04/16/2021

Labeler — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)

Registrant — AVET LIFESCIENCES PRIVATE LIMITED (853181664)

Establishment
Name	Address	ID/FEI	Operations
RA CHEM PHARMA LIMITED		677637710	MANUFACTURE (23155-147), MANUFACTURE (23155-148), MANUFACTURE (23155-149)

Establishment
Name	Address	ID/FEI	Operations
CorePharma, LLC		031192276	manufacture (23155-147), manufacture (23155-148), manufacture (23155-149)

Revised: 03/2023 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.