Zidovudine

Product NDC: 31722-509
Requested package NDC: 31722-509-60
11-digit product format: 317220509
Labeler code: 31722
Product ID: 31722-509_fbbb4305-5ef7-b4b5-e053-6294a90a278c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zidovudine
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA090092
Marketing category: ANDA
Marketing start: 2008-04-25
Substance: ZIDOVUDINE
Active strength: 300 mg/1
Pharmacologic classes: 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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	31722-509	31722-509-60	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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
A090092-001	ZIDOVUDINE	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090092-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090092-001	ZIDOVUDINE	300MG	TABLET / ORAL	AB	RS	2008-04-25	`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	A090092-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090092-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090092-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090092-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090092-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090092-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090092-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090092-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090092-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090092-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090092-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090092-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090092-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090092-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090092-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090092-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090092-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090092-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090092-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090092-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090092-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090092-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090092-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090092-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090092-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090092-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090092-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090092-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090092-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090092-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090092-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090092-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090092-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090092-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090092-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090092-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090092-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090092-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090092-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090092-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zidovudine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZIDOVUDINE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199663	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
ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
e1098f43-eafb-82a0-ef30-575f1d8189b0	Product name	2	20150227
9ceb457b-0c09-9326-bbca-f296202d412c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
31722-509-60	2023-05-15	C162847	48780-1	f386c64a-1347-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for ZIDOVUDINE TABLETS. ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1987
31722-509-60	2023-01-30	C162847	48780-1	f386c64a-1347-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for ZIDOVUDINE TABLETS. ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
31722-509-60	Zidovudine	60 in 1 BOTTLE	TABLET	60		5
31722-509-60	Zidovudine	12 in 1 CASE	TABLET	12		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-509-60	EA - Each	31722-509	687ff579-e4b5-47bd-aba5-eeef56dd6390	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZIDOVUDINE	ACTIVE INGREDIENT	4B9XT59T7S	ZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]	1
ZIDOVUDINE	ACTIVE MOIETY	4B9XT59T7S	ZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIDOVUDINE TABLET [CAMBER PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-509	ZIDOVUDINE (ZIDOVUDINE) TABLET [CAMBER PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20230517_ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zidovudine	ZIDOVUDINE	Coupler LLC	437f55b2-f6d9-0065-e063-6294a90ab929	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090092 application number: ANDA090092
Zidovudine	ZIDOVUDINE	Camber Pharmaceuticals, Inc.	ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4	2023-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090092 application number: ANDA090092 ndc (package): 31722-509-60 ndc (product): 31722-509 ndc11 (package): 31722050960

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199663	zidovudine 300 MG Oral Tablet	PSN	ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4	5
199663	zidovudine 300 MG Oral Tablet	SCD	ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4	5
199663	AZT 300 MG Oral Tablet	SY	ca9f0c57-fc8b-4da4-a987-0fc52b7fd4f4	5
199663	zidovudine 300 MG Oral Tablet	PSN	437f55b2-f6d9-0065-e063-6294a90ab929	2
199663	zidovudine 300 MG Oral Tablet	SCD	437f55b2-f6d9-0065-e063-6294a90ab929	2
199663	AZT 300 MG Oral Tablet	SY	437f55b2-f6d9-0065-e063-6294a90ab929	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-509-60	31722050960	12 BOTTLE in 1 CASE (31722-509-60) / 60 TABLET in 1 BOTTLE	12 bottle	2008-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zidovudine	Coupler LLC	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Zidovudine	REMEDYREPACK INC.	2024-04-12	HUMAN PRESCRIPTION DRUG LABEL	10
Zidovudine	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2023-05-15	HUMAN PRESCRIPTION DRUG LABEL	5