Zidovudine

Product NDC: 65862-107
Requested package NDC: 65862-107-26
11-digit product format: 658620107
Labeler code: 65862
Product ID: 65862-107_6da825d2-eacc-4a7d-98dc-7af924a9af92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zidovudine
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078128
Marketing category: ANDA
Marketing start: 2006-03-27
Substance: ZIDOVUDINE
Active strength: 100 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

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
unfinished package	package	65862-107	65862-107-26	UNFINISHED	Active or certified unfinished drug listing		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 · 21 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZIDOVUDINE	100 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
198352	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
9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-107-01	Zidovudine	100 in 1 BOTTLE	CAPSULE	100	19
65862-107-10	Zidovudine	10 in 1 BLISTER PACK	CAPSULE	10	19
65862-107-10	Zidovudine	10 in 1 CARTON	CAPSULE	10	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-107-01	EA - Each	65862-107	60db3b9b-89f1-4a78-a5e1-b82ca5872940	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZIDOVUDINE	ACTIVE INGREDIENT	4B9XT59T7S	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9
ZIDOVUDINE	ACTIVE MOIETY	4B9XT59T7S	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-107	ZIDOVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	19	Current NDC, Legacy NDC, 3 package rows	20250216_9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf.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
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 ndc (product): 65862-107

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
198352	zidovudine 100 MG Oral Capsule	PSN	9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf	19
198352	zidovudine 100 MG Oral Capsule	SCD	9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf	19
198352	AZT 100 MG Oral Capsule	SY	9907acb2-e4a0-46f9-93c0-a8d7b7ce98cf	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-107-26	65862010726	2500 CAPSULE in 1 BAG (65862-107-26)	2500 capsule	27-MAR-06	Current