ABACAVIR AND LAMIVUDINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)

Available from:

Zydus Lifesciences Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine is contraindicated in patients: - who have the HLA-B*5701 allele [see Warnings and Precautions (5.1)] . - with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1)] or lamivudine. - with moderate or severe hepatic impairment [see Use in Specific Populations (8.7)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital

Product summary:

Abacavir and lamivudine tablets, USP contain 600 mg of abacavir (equivalent to 702.00 mg abacavir sulfate, USP) and 300 mg of lamivudine, USP. Abacavir and Lamivudine Tablets USP, 600 mg/300 mg are light yellow to yellow, modified capsule shaped, coated tablets, debossed with "1049" on one side and plain on the other side and are supplied as: NDC 70771-1053-3 in bottle of 30 tablets with child-resistant closure NDC 70771-1053-9 in bottle of 90 tablets with child-resistant closure Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: 47fd1d3f-78d9-4585-aa16-97f863500b58
34391-3
Set id: 3709b07b-a37d-4ffb-92fa-5c0dd9b973b7
Version: 6
Effective Time: 20230927
Zydus Lifesciences Limited

Summary of Product characteristics

ABACAVIR AND LAMIVUDINE- ABACAVIR AND LAMIVUDINE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
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ABACAVIR AND LAMIVUDINE TABLETS, FOR ORAL USE
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1053-9
Abacavir and Lamivudine Tablets, 600 mg/300 mg
90 Tablets
Rx only
ABACAVIR SULFATE AND LAMIVUDINE TABLET:
WARNING CARD
ABACAVIR AND LAMIVUDINE
abacavir and lamivudine tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1053
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)
ABACAVIR
600 mg
LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)
LAMIVUDINE
300 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE K30 (UNII: U725QWY32X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (LIGHT YELLOW TO YELLOW)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
20mm
FLAVOR
IMPRINT CODE
1049
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1053-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
03/14/2019
2
NDC:70771-
1053-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
03/14/2019
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA208990
03/14/2019
Zydus Lifesciences Limited
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
863362789
ANALYSIS(70771-1053) , MANUFACTURE(70771-1053)
Revised: 9/