ABACAVIR, LAMIVUDINE AND ZIDOVUDINE

Product NDC: 68180-286
Requested package NDC: 68180-286-02
11-digit product format: 681800286
Labeler code: 68180
Product ID: 68180-286_e180b9ff-1e7c-422a-9fe7-afd39eee3e4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ABACAVIR , LAMIVUDINE AND ZIDOVUDINE
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA202912
Marketing category: ANDA
Marketing start: 2013-12-17
Substance: LAMIVUDINE; ZIDOVUDINE; ABACAVIR SULFATE
Active strength: 150; 300; 300 mg/1; mg/1; mg/1
Pharmacologic classes: Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL			2013-12-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL			2013-12-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL			2013-12-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL			2013-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL		RS	2013-12-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202912-001	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE	EQ 300MG BASE;150MG;300MG	TABLET / ORAL	AB		2013-12-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202912-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202912-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202912-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202912-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202912-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202912-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202912-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202912-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202912-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202912-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202912-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202912-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202912-001	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A202912-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202912-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202912-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202912-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202912-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202912-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202912-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202912-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202912-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202912-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202912-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ABACAVIR, LAMIVUDINE AND ZIDOVUDINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAMIVUDINE	150 mg/1
ZIDOVUDINE	300 mg/1
ABACAVIR SULFATE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2T8Q726O95	Internal UNII lookup
4B9XT59T7S	Internal UNII lookup
J220T4J9Q2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307650	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f5f7c0d9-a247-4308-8269-32accc490ea6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
aaa99659-c62c-7281-d402-9590409850c2	Product name	6	20260128
a02e6d35-8cc4-a80a-fd4d-d3ec16f69b8e	Product name	8	20250626
4ef90d80-1289-4267-a2bb-01c741d1208f	Product name	1	20230829
72dcca4e-6eae-4149-a92b-264c2a07004f	Product name	1	20230808
3832141c-c294-474a-9473-1052c891450e	Product name	2	20230105
320f244d-8b4e-4893-9f14-104b2a8e0aaf	Product name	2	20201007
7ff71f22-5b66-4a3d-bf64-671893a6409d	Product name	2	20201007
3644e9cf-6f4d-4b63-b875-6a4b5187c47e	Product name	1	20190703
0e579b5c-f0b5-e690-466e-4a5e809e2c68	Product name	3	20190627
6f122144-2ceb-48fa-a906-0d2eb742717e	Product name	1	20190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
fbdbfbef-2c33-0298-4fef-f6693e670fe1	Product name	7	20181210
d07e0b9e-e041-41dc-942a-a2a6601dc221	Product name	1	20181029
e1e3cf65-28b8-ebf3-c11f-d11a82e0862a	Product name	4	20180604
af19b329-4f44-cd81-491a-fbb7fe7a079f	Product name	2	20151013
c873f14e-2add-4d53-b9b3-bf775efd3702	Product name	1	20150325
e1098f43-eafb-82a0-ef30-575f1d8189b0	Product name	2	20150227
9ceb457b-0c09-9326-bbca-f296202d412c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68180-286-01	ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	1 in 1 CARTON	TABLET	1	16
68180-286-01	ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	100 in 1 BOTTLE	TABLET	100	16
68180-286-02	ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	500 in 1 BOTTLE	TABLET	500	16
68180-286-02	ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	1 in 1 CARTON	TABLET	1	16
68180-286-07	ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	1 in 1 CARTON	TABLET	1	16
68180-286-07	ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	60 in 1 BOTTLE	TABLET	60	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-286-07	EA - Each	68180-286	aa35b5fe-1207-470f-bcfc-c095a0f12572	1	2014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ABACAVIR SULFATE	ACTIVE INGREDIENT	J220T4J9Q2	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
LAMIVUDINE	ACTIVE INGREDIENT	2T8Q726O95	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
ZIDOVUDINE	ACTIVE INGREDIENT	4B9XT59T7S	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
ABACAVIR	ACTIVE MOIETY	WR2TIP26VS	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
LAMIVUDINE	ACTIVE MOIETY	2T8Q726O95	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
ZIDOVUDINE	ACTIVE MOIETY	4B9XT59T7S	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET [LUPIN PHARMACEUTICALS, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-286	ABACAVIR, LAMIVUDINE AND ZIDOVUDINE (ABACAVIR , LAMIVUDINE AND ZIDOVUDINE) TABLET [LUPIN PHARMACEUTICALS, INC.]	16	Current NDC, Legacy NDC, 6 package rows	20231102_f5f7c0d9-a247-4308-8269-32accc490ea6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	ABACAVIR , LAMIVUDINE AND ZIDOVUDINE	Lupin Pharmaceuticals, Inc.	f5f7c0d9-a247-4308-8269-32accc490ea6	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202912 application number: ANDA202912 ndc (package): 68180-286-02 ndc (product): 68180-286 ndc11 (package): 68180028602

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2T8Q726O95	LAMIVUDINE	134678-17-4	LAMIVUDINE
4B9XT59T7S	ZIDOVUDINE	30516-87-1	ZIDOVUDINE
J220T4J9Q2	ABACAVIR SULFATE	188062-50-2	ABACAVIR SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307650	abacavir sulfate 300 MG / lamiVUDine 150 MG / zidovudine 300 MG Oral Tablet	PSN	f5f7c0d9-a247-4308-8269-32accc490ea6	16
307650	abacavir 300 MG / lamivudine 150 MG / zidovudine 300 MG Oral Tablet	SCD	f5f7c0d9-a247-4308-8269-32accc490ea6	16
307650	abacavir (as abacavir sulfate) 300 MG / 3TC 150 MG / AZT 300 MG Oral Tablet	SY	f5f7c0d9-a247-4308-8269-32accc490ea6	16
307650	abacavir 300 MG / 3TC 150 MG / AZT 300 MG Oral Tablet	SY	f5f7c0d9-a247-4308-8269-32accc490ea6	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-286-02	68180028602	1 BOTTLE in 1 CARTON (68180-286-02) > 500 TABLET in 1 BOTTLE	1 bottle	2013-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2023-10-31	HUMAN PRESCRIPTION DRUG LABEL	16