nevirapine

Product NDC: 53104-0166
11-digit product format: 531040166
Labeler code: 53104
Product ID: 53104-0166_caf42378-e171-46e5-9fd5-c02a9823616e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nevirapine
Dosage form: TABLET
Route: ORAL
Labeler: Cipla Ltd.
Application: ANDA077956
Marketing category: ANDA
Marketing start: 2012-05-22
Marketing end: 0000-00-00
Substance: NEVIRAPINE
Active strength: 200 mg/1
Pharmacologic classes: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [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	53104-0166		I	Inactivated by FDA	2026-08-17
excluded package	package	53104-0166	53104-0166-2	I	Inactivated by FDA	2026-08-17
excluded package	package	53104-0166	53104-0166-6	I	Inactivated by FDA	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	53104-0166-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53104-0166-2	`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	53104-0166-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53104-0166-2	`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	53104-0166-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53104-0166-2	`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	53104-0166-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53104-0166-2	`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	53104-0166-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53104-0166-2	`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	53104-0166-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53104-0166-2	`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	53104-0166-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53104-0166-2	`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	53104-0166-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53104-0166-2	`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	53104-0166-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53104-0166-2	`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	53104-0166-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53104-0166-2	`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	53104-0166-6	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53104-0166-2	`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	53104-0166-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53104-0166-2	`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	53104-0166-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53104-0166-2	`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	53104-0166-6	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53104-0166-2	`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	53104-0166-6	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53104-0166-2	`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	53104-0166-6	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53104-0166-2	`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	53104-0166-6	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53104-0166-2	`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	53104-0166-6	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53104-0166-2	`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	53104-0166-6	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53104-0166-2	`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	53104-0166-6	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53104-0166-2	`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
A077956-001	NEVIRAPINE	NEVIRAPINE	200MG	TABLET / ORAL	AB		2012-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077956-001	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	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077956-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`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	A077956-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077956-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077956-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077956-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077956-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077956-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077956-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077956-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077956-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077956-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077956-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077956-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077956-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077956-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077956-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077956-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077956-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077956-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077956-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077956-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077956-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077956-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077956-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077956-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077956-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077956-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077956-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077956-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077956-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077956-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077956-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077956-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077956-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077956-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077956-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077956-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077956-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077956-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077956-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077956-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a1bab0e5-3c0a-775a-2f29-a19e4e281871	Product name	3	20190610
d07e0b9e-e041-41dc-942a-a2a6601dc221	Product name	1	20181029
0d48f664-b8cd-5c4b-aa8e-0a00f1c0002d	Product name	8	20171204

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53104-0166-2	2020-01-31	C162847	48780-1	9d75b9d0-145c-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NEVIRAPINE TABLETS safely and effectively. See full prescribing information for NEVIRAPINE TABLETS. NEVIRAPINE Tablets USP, 200 mg, for oral use Initial U.S. Approval: 1996
53104-0166-6	2020-01-31	C162847	48780-1	9d75b9d0-145c-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use NEVIRAPINE TABLETS safely and effectively. See full prescribing information for NEVIRAPINE TABLETS. NEVIRAPINE Tablets USP, 200 mg, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53104-0166-2	nevirapine	60 in 1 BOTTLE	TABLET	60		6
53104-0166-6	nevirapine	1000 in 1 BOTTLE	TABLET	1000		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NEVIRAPINE	ACTIVE INGREDIENT	99DK7FVK1H	NEVIRAPINE TABLET [CIPLA LIMITED]	2
NEVIRAPINE	ACTIVE MOIETY	99DK7FVK1H	NEVIRAPINE TABLET [CIPLA LIMITED]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NEVIRAPINE TABLET [CIPLA LIMITED]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NEVIRAPINE TABLET [CIPLA LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NEVIRAPINE TABLET [CIPLA LIMITED]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NEVIRAPINE TABLET [CIPLA LIMITED]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NEVIRAPINE TABLET [CIPLA LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53104-0166	NEVIRAPINE TABLET [CIPLA LTD.]	6	Legacy NDC, 2 package rows	20181218_4d056e75-6122-4733-96cc-b21c7c944192.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
99DK7FVK1H	NEVIRAPINE	129618-40-2	NEVIRAPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199422	nevirapine 200 MG Oral Tablet	PSN	4d056e75-6122-4733-96cc-b21c7c944192	6
199422	nevirapine 200 MG Oral Tablet	SCD	4d056e75-6122-4733-96cc-b21c7c944192	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53104-0166-2	53104016602	60 in 1 BOTTLE	Historical
53104-0166-6	53104016606	1000 in 1 BOTTLE	Historical