Nevirapine

Product NDC: 53808-0680
11-digit product format: 538080680
Labeler code: 53808
Product ID: 53808-0680_e15b05c5-0ba5-4f29-985a-63d8ec3f97af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nevirapine
Dosage form: TABLET
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA202523
Marketing category: ANDA
Marketing start: 2013-01-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0680		I	Inactivated by FDA		2026-08-17
excluded package	package	53808-0680	53808-0680-1	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 1 · 42 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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`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	53808-0680-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0680-1	`9bebd1f3094a…`	`5416666fcb17…`

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
A202523-001	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
A202523-001	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	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202523-001	NEVIRAPINE	200MG	TABLET / ORAL	AB	2012-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202523-001	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	A202523-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202523-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202523-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202523-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202523-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202523-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202523-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202523-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202523-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202523-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202523-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202523-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202523-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202523-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202523-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202523-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202523-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202523-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202523-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202523-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202523-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202523-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202523-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202523-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202523-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202523-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202523-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202523-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202523-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202523-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202523-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202523-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202523-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202523-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202523-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202523-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202523-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202523-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202523-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202523-001	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
53808-0680-1	2020-01-31	C162847	48780-1	9d75b9d0-7baf-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 Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0680-1	Nevirapine	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NEVIRAPINE	ACTIVE INGREDIENT	99DK7FVK1H	NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
NEVIRAPINE	ACTIVE MOIETY	99DK7FVK1H	NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0680	NEVIRAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20140415_e6267bd6-dd60-48d7-969c-c3ebaf113eb7.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
Nevirapine	NEVIRAPINE	Mylan Pharmaceuticals Inc.	c6e93829-7024-48f6-8023-da6ff27dfc0a	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202523 application number: ANDA202523

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	e6267bd6-dd60-48d7-969c-c3ebaf113eb7	1
199422	nevirapine 200 MG Oral Tablet	SCD	e6267bd6-dd60-48d7-969c-c3ebaf113eb7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0680-1	53808068001	30 in 1 BLISTER PACK	Historical