Zidovudine

Product NDC: 52343-044
Requested package NDC: 52343-044-01
11-digit product format: 523430044
Labeler code: 52343
Product ID: 52343-044_f238bbef-cbea-49ed-8e09-8c0fa73b4f36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zidovudine
Dosage form: CAPSULE
Route: ORAL
Labeler: ACETRIS HEALTH, LLC
Application: ANDA078128
Marketing category: ANDA
Marketing start: 2006-03-27
Marketing end: 0000-00-00
Substance: ZIDOVUDINE
Active strength: 100 mg/1
Pharmacologic classes: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	52343-044	52343-044-01	D	Discontinued by firm		2026-08-17

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 42.

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
A078128-001	ZIDOVUDINE	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB		2006-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078128-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078128-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2006-03-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078128-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078128-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078128-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078128-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078128-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078128-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078128-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078128-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078128-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078128-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078128-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078128-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078128-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078128-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078128-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078128-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078128-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078128-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078128-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078128-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078128-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078128-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078128-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078128-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078128-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078128-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078128-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078128-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078128-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078128-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078128-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078128-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078128-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078128-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078128-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078128-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078128-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078128-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078128-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078128-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52343-044-01	EA - Each	52343-044	eaec7c24-dc81-42c8-9b1a-269f0b890d18	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZIDOVUDINE	ACTIVE INGREDIENT	4B9XT59T7S	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1
ZIDOVUDINE	ACTIVE MOIETY	4B9XT59T7S	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIDOVUDINE CAPSULE [GEN-SOURCE RX]	1

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
Zidovudine	ZIDOVUDINE	Aurobindo Pharma Limited	9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078128 application number: ANDA078128

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4B9XT59T7S	ZIDOVUDINE	30516-87-1	ZIDOVUDINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52343-044-01	52343004401	100 CAPSULE in 1 BOTTLE (52343-044-01)	100 capsule	2006-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zidovudine	ACETRIS HEALTH, LLC \| Aurobindo Pharma Limited	2019-01-08	Human Prescription Drug Label	4