Home NDC 31722-505-01 Nevirapine
Product NDC 31722-505
Requested package NDC 31722-505-01
11-digit product format 317220505
Labeler code 31722
Product ID 31722-505_e5515515-0ee0-e288-e053-2995a90a3d7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nevirapine
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA078584
Marketing category ANDA
Marketing start 2012-05-23
Substance NEVIRAPINE
Active strength 200 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 1 .
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 A078584-001 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 A078584-001 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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078584-001 NEVIRAPINE 200MG TABLET / ORAL AB 2012-05-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nevirapine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEVIRAPINE 200 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 199422 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 31722-505-01 Nevirapine 100 in 1 BOTTLE TABLET 100 15 31722-505-05 Nevirapine 500 in 1 BOTTLE TABLET 500 15 31722-505-10 Nevirapine 1000 in 1 BOTTLE TABLET 1000 15 31722-505-60 Nevirapine 60 in 1 BOTTLE TABLET 60 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NEVIRAPINE ACTIVE INGREDIENT 99DK7FVK1H NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 NEVIRAPINE ACTIVE MOIETY 99DK7FVK1H NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 POVIDONE INACTIVE INGREDIENT FZ989GH94E NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NEVIRAPINE TABLET [CAMBER PHARMACEUTICALS, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-505 NEVIRAPINE (NEVIRAPINE) TABLET [CAMBER PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 4 package rows 20220805_61409678-d2f6-42cd-b03d-b26b11b39641.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 31722-505-01 31722050501 100 TABLET in 1 BOTTLE (31722-505-01) 100 tablet 2012-05-23 0000-00-00 No No Current