LAMIVUDINE and ZIDOVUDINE

Product NDC: 68788-7298
Requested package NDC: 68788-7298-8
11-digit product format: 687887298
Labeler code: 68788
Product ID: 68788-7298_a294cebc-dd1b-4780-a9f6-d98308ea4ad1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LAMIVUDINE and ZIDOVUDINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA079124
Marketing category: ANDA
Marketing start: 2019-01-04
Marketing end: 0000-00-00
Substance: LAMIVUDINE; ZIDOVUDINE
Active strength: 150 mg/1; mg/1
Pharmacologic classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7298	68788-7298-8	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A079124-001	LAMIVUDINE AND ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079124-001	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 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	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB	RS	2015-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079124-001	LAMIVUDINE AND ZIDOVUDINE	150MG;300MG	TABLET / ORAL	AB		2015-09-17	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A079124-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079124-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079124-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079124-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079124-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079124-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079124-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079124-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079124-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079124-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079124-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079124-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079124-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079124-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079124-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079124-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079124-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079124-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079124-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079124-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079124-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079124-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079124-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079124-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079124-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079124-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079124-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079124-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079124-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079124-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079124-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079124-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079124-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079124-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079124-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079124-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079124-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079124-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079124-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079124-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7298-1	EA - Each	68788-7298	19e7af75-6275-481c-a6fa-6bda4ca52e5c	1	2019-04-11
68788-7298-2	EA - Each	68788-7298	521ae5ef-a2a6-4c33-a8c0-dc1c5756ff2d	1	2019-04-11
68788-7298-3	EA - Each	68788-7298	c11e621b-e78d-48d7-ac39-90a76ce94937	1	2019-04-11
68788-7298-4	EA - Each	68788-7298	4a7db81a-ccd7-4d5a-97aa-b29314bd1de1	1	2019-04-11
68788-7298-6	EA - Each	68788-7298	004e6ff3-acb7-47e6-8fa1-bcb507a62d38	1	2019-04-11
68788-7298-8	EA - Each	68788-7298	1636aa75-bd01-4083-afdd-b20e90b3a2f7	1	2019-04-11
68788-7298-9	EA - Each	68788-7298	cdb7dfe8-0e4e-4c12-9fdf-64563f46e607	1	2019-04-11

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LAMIVUDINE and ZIDOVUDINE	LAMIVUDINE AND ZIDOVUDINE	PD-Rx Pharmaceuticals, Inc.	ff62c5fc-965d-4534-a571-a4f290cb9d83	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079124 application number: ANDA079124
LAMIVUDINE and ZIDOVUDINE	LAMIVUDINE AND ZIDOVUDINE	Bryant Ranch Prepack	005f1b9d-1950-4ef3-a9d6-c428a40a3630	2023-03-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079124 application number: ANDA079124
LAMIVUDINE and ZIDOVUDINE	LAMIVUDINE AND ZIDOVUDINE	Camber Pharmaceuticals, Inc.	f80bd0f3-47eb-4b82-a633-4536cf376cf6	2022-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079124 application number: ANDA079124

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7298-8	68788729808	120 TABLET, FILM COATED in 1 BOTTLE (68788-7298-8)	2019-01-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LAMIVUDINE and ZIDOVUDINE	Preferred Pharmaceuticals Inc.	2020-06-19	HUMAN PRESCRIPTION DRUG LABEL	4