Zidovudine

Product NDC: 53104-0100
11-digit product format: 531040100
Labeler code: 53104
Product ID: 53104-0100_412da56b-a627-40fa-a943-900540bdd9ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zidovudine
Dosage form: CAPSULE
Route: ORAL
Labeler: Cipla Ltd.
Application: ANDA078349
Marketing category: ANDA
Marketing start: 2007-05-23
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: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53104-0100		D	Discontinued by firm	2026-08-17
excluded package	package	53104-0100	53104-0100-4	D	Discontinued by firm	2026-08-17
excluded package	package	53104-0100	53104-0100-6	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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53104-0100-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53104-0100-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53104-0100-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53104-0100-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53104-0100-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53104-0100-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53104-0100-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53104-0100-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53104-0100-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53104-0100-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53104-0100-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53104-0100-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53104-0100-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53104-0100-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53104-0100-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53104-0100-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53104-0100-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53104-0100-4	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53104-0100-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53104-0100-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53104-0100-6	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53104-0100-4	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53104-0100-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53104-0100-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53104-0100-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53104-0100-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53104-0100-6	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53104-0100-4	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53104-0100-6	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53104-0100-4	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53104-0100-6	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53104-0100-4	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53104-0100-6	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53104-0100-4	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53104-0100-6	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53104-0100-4	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53104-0100-6	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53104-0100-4	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53104-0100-6	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53104-0100-4	`e2bbac7714bc…`	`27bdfed8d636…`

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
A078349-001	ZIDOVUDINE	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB		2007-05-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078349-001	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	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078349-001	ZIDOVUDINE	100MG	CAPSULE / ORAL	AB	2007-05-23	`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	A078349-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078349-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078349-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078349-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078349-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078349-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078349-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078349-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078349-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078349-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078349-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078349-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078349-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078349-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078349-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078349-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078349-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078349-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078349-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078349-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078349-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078349-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078349-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078349-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078349-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078349-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078349-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078349-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078349-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078349-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078349-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078349-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078349-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078349-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078349-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078349-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078349-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078349-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078349-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078349-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53104-0100-4	2025-12-23	These highlights do not include all the information needed to use ZIDOVUDINE CAPSULES safely and effectively. See full prescribing information for ZIDOVUDINE CAPSULES. ZIDOVUDINE capsules, for oral use Initial U.S. Approval: 1987
53104-0100-6	2025-12-23	These highlights do not include all the information needed to use ZIDOVUDINE CAPSULES safely and effectively. See full prescribing information for ZIDOVUDINE CAPSULES. ZIDOVUDINE capsules, for oral use Initial U.S. Approval: 1987
53104-0100-4	2020-01-31	These highlights do not include all the information needed to use ZIDOVUDINE CAPSULES safely and effectively. See full prescribing information for ZIDOVUDINE CAPSULES. ZIDOVUDINE capsules, for oral use Initial U.S. Approval: 1987
53104-0100-6	2020-01-31	These highlights do not include all the information needed to use ZIDOVUDINE CAPSULES safely and effectively. See full prescribing information for ZIDOVUDINE CAPSULES. ZIDOVUDINE capsules, for oral use Initial U.S. Approval: 1987

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZIDOVUDINE	ACTIVE INGREDIENT	4B9XT59T7S	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
ZIDOVUDINE	ACTIVE MOIETY	4B9XT59T7S	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZIDOVUDINE CAPSULE [CIPLA LTD.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53104-0100	ZIDOVUDINE CAPSULE [CIPLA LTD.]	13	Legacy NDC	20181130_536735fc-566c-4ad4-b83e-602199ff82b4.zip