Nevirapine

Product NDC: 0378-4890
11-digit product format: 003784890
Labeler code: 0378
Product ID: 0378-4890_750bda83-d972-44e2-85ae-26676e1e7c34
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nevirapine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA205651
Marketing category: ANDA
Marketing start: 2014-10-29
Substance: NEVIRAPINE
Active strength: 400 mg/1
Pharmacologic classes: Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A205651-001	NEVIRAPINE	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2014-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205651-001	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	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205651-001	NEVIRAPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-10-27	`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	A205651-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205651-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205651-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205651-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205651-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205651-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205651-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205651-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205651-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205651-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205651-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205651-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205651-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205651-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205651-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205651-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205651-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205651-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205651-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205651-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205651-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205651-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205651-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205651-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205651-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205651-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205651-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205651-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205651-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205651-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205651-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205651-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205651-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205651-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205651-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205651-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205651-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205651-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205651-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205651-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEVIRAPINE	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
99DK7FVK1H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1095712	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
690da74b-2481-47fc-93ae-8340e0caf0a4	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-4890-93	Nevirapine	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4890-93	EA - Each	0378-4890	2aa100c1-c64f-4367-8562-043a7467a0eb	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NEVIRAPINE	ACTIVE INGREDIENT	99DK7FVK1H	NEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	1
NEVIRAPINE	ACTIVE MOIETY	99DK7FVK1H	NEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	NEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-4890	NEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	10	Current NDC, Legacy NDC, 1 package rows	20250116_690da74b-2481-47fc-93ae-8340e0caf0a4.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.	690da74b-2481-47fc-93ae-8340e0caf0a4	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205651 application number: ANDA205651 ndc (product): 0378-4890

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
1095712	nevirapine 400 MG 24HR Extended Release Oral Tablet	PSN	690da74b-2481-47fc-93ae-8340e0caf0a4	10
1095712	24 HR nevirapine 400 MG Extended Release Oral Tablet	SCD	690da74b-2481-47fc-93ae-8340e0caf0a4	10
1095712	nevirapine 400 MG 24 HR Extended Release Oral Tablet	SY	690da74b-2481-47fc-93ae-8340e0caf0a4	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-4890-93	00378489093	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4890-93)	2014-10-29	0000-00-00	No	No	Current