Nevirapine

Product NDC
0781-5893
11-digit product format
007815893
Labeler code
0781
Product ID
0781-5893_71d555c0-49ff-4c9b-a3ee-dbbe89efbf5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nevirapine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA203411
Marketing category
ANDA
Marketing start
2014-04-15
Marketing end
0000-00-00
Substance
NEVIRAPINE
Active strength
400 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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-5893DDiscontinued by firm2026-08-17
excluded packagepackage0781-58930781-5893-05DDiscontinued by firm2026-08-17
excluded packagepackage0781-58930781-5893-31DDiscontinued by firm2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5893-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5893-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5893-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5893-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5893-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5893-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5893-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5893-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5893-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5893-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5893-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5893-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5893-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5893-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5893-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5893-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5893-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5893-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5893-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5893-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5893-31367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5893-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5893-31557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5893-05557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203411-001NEVIRAPINENEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203411-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-033f01610625f2…
2019-09-15 20:21 UTC2019-09A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203411-001NEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALAB2014-04-03e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203411-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203411-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203411-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203411-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203411-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203411-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203411-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203411-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203411-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203411-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203411-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203411-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203411-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203411-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203411-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203411-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203411-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203411-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203411-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203411-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203411-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203411-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203411-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203411-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203411-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203411-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203411-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203411-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203411-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203411-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203411-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203411-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203411-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203411-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203411-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203411-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203411-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203411-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203411-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203411-001AB1e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5893-31EA - Each0781-5893097d3d32-c145-4908-90f8-9d24dcf7cb0712014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEVIRAPINEACTIVE INGREDIENT99DK7FVK1HNEVIRAPINE TABLET, EXTENDED RELEASE [SANDOZ INC]13
NEVIRAPINEACTIVE MOIETY99DK7FVK1HNEVIRAPINE TABLET, EXTENDED RELEASE [SANDOZ INC]13
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNEVIRAPINE TABLET, EXTENDED RELEASE [SANDOZ INC]13
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TNEVIRAPINE TABLET, EXTENDED RELEASE [SANDOZ INC]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNEVIRAPINE TABLET, EXTENDED RELEASE [SANDOZ INC]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NEVIRAPINE TABLET, EXTENDED RELEASE [SANDOZ INC]13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5893-0500781589305500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5893-05) 2014-04-150000-00-00NoNoCurrent
0781-5893-310078158933130 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5893-31) 2014-04-150000-00-00NoNoCurrent