Lamivudine

Product NDC: 60687-720
Requested package NDC: 60687-720-21
11-digit product format: 606870720
Labeler code: 60687
Product ID: 60687-720_223f034f-e646-cd65-e063-6394a90a3505
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamivudine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA091606
Marketing category: ANDA
Marketing start: 2023-01-19
Substance: LAMIVUDINE
Active strength: 150 mg/1
Pharmacologic classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091606-001	LAMIVUDINE	LAMIVUDINE	150MG	TABLET / ORAL	AB		2011-12-02
A091606-002	LAMIVUDINE	LAMIVUDINE	300MG	TABLET / ORAL	AB		2011-12-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091606-001	AB
A091606-002	AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091606-001	LAMIVUDINE	150MG	TABLET / ORAL	AB	2011-12-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091606-002	LAMIVUDINE	300MG	TABLET / ORAL	AB	2011-12-02	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091606-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091606-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091606-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091606-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091606-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091606-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091606-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091606-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091606-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091606-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091606-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091606-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091606-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091606-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091606-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091606-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091606-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091606-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091606-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091606-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091606-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091606-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091606-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091606-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091606-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091606-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091606-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091606-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091606-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091606-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091606-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091606-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091606-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091606-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091606-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091606-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091606-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091606-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091606-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091606-002	AB	1	`74a2ff9319b5…`

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: Lamivudine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAMIVUDINE	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199147	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
7ad3a998-8e4d-43a0-8930-8f7a6ae539b4	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
af19b329-4f44-cd81-491a-fbb7fe7a079f	Product name	2	20151013
c873f14e-2add-4d53-b9b3-bf775efd3702	Product name	1	20150325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60687-720-11	Lamivudine	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2
60687-720-21	Lamivudine	30 in 1 CARTON	TABLET, FILM COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-720-11	EA - Each	60687-720	fb113567-10b8-40d2-8ccb-a26f2a22bfb5	1	2023-02-06
60687-720-21	EA - Each	60687-720	48cfb5a7-de98-48f3-a47b-5ce94a17e9f2	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-720	LAMIVUDINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	2	Current NDC, Legacy NDC, 2 package rows	20240919_7ad3a998-8e4d-43a0-8930-8f7a6ae539b4.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LAMIVUDINE	LAMIVUDINE	Major Pharmaceuticals	6fd4d6b9-65ea-4988-8d6f-dd220ec5052d	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091606 application number: ANDA091606
LAMIVUDINE	LAMIVUDINE	Golden State Medical Supply, Inc.	f3637209-303e-4232-ae79-07315a990973	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091606 application number: ANDA091606
LAMIVUDINE	LAMIVUDINE	Apotex Corp.	34c02bcc-d6ff-99d4-8e6a-4a91908adca8	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091606 application number: ANDA091606
Lamivudine	LAMIVUDINE	American Health Packaging	7ad3a998-8e4d-43a0-8930-8f7a6ae539b4	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091606 application number: ANDA091606 ndc (package): 60687-720-21 ndc (product): 60687-720 ndc11 (package): 60687072021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2T8Q726O95	LAMIVUDINE	134678-17-4	LAMIVUDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199147	lamiVUDine 150 MG Oral Tablet	PSN	7ad3a998-8e4d-43a0-8930-8f7a6ae539b4	2
199147	lamivudine 150 MG Oral Tablet	SCD	7ad3a998-8e4d-43a0-8930-8f7a6ae539b4	2
199147	3TC 150 MG Oral Tablet	SY	7ad3a998-8e4d-43a0-8930-8f7a6ae539b4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-720-21	60687072021	30 BLISTER PACK in 1 CARTON (60687-720-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-720-11)	30 blister pack	2023-01-19	0000-00-00	No	No	Current