Stavudine

Product NDC: 65862-047
11-digit product format: 658620047
Labeler code: 65862
Product ID: 65862-047_83323ad0-d1e7-4d17-a008-ed075ad5ffac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Stavudine
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA077672
Marketing category: ANDA
Marketing start: 2008-12-29
Marketing end: 0000-00-00
Substance: STAVUDINE
Active strength: 40 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65862-047		D	Discontinued by firm		2026-10-05
excluded package	package	65862-047	65862-047-60	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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65862-047-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-047-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-047-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-047-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-047-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-047-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-047-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-047-18	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077672-001	STAVUDINE	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29
A077672-002	STAVUDINE	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29
A077672-003	STAVUDINE	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29
A077672-004	STAVUDINE	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077672-001	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077672-002	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077672-003	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077672-004	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077672-001	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077672-002	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077672-003	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077672-004	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077672-001	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077672-002	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077672-003	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077672-004	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077672-001	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077672-002	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077672-003	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077672-004	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077672-001	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077672-002	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077672-003	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077672-004	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077672-001	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077672-002	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077672-003	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077672-004	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077672-001	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077672-002	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077672-003	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077672-004	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077672-001	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077672-002	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077672-003	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077672-004	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077672-001	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077672-002	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077672-003	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077672-004	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077672-001	STAVUDINE	30MG	CAPSULE / ORAL	2008-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077672-002	STAVUDINE	40MG	CAPSULE / ORAL	2008-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077672-003	STAVUDINE	15MG	CAPSULE / ORAL	2008-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077672-004	STAVUDINE	20MG	CAPSULE / ORAL	2008-12-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077672-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077672-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077672-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077672-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077672-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077672-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077672-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077672-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077672-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077672-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077672-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077672-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077672-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077672-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077672-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077672-004	AB	1	`ea99ee380514…`

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
65862-047-60	EA - Each	65862-047	6e821de3-0fb3-4e3a-9dcf-3573f657a4bc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
STAVUDINE	ACTIVE INGREDIENT	BO9LE4QFZF	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
STAVUDINE	ACTIVE MOIETY	BO9LE4QFZF	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	STAVUDINE CAPSULE [AUROBINDO PHARMA LIMITED]	8