Home NDC 0378-4050 Nevirapine
Product NDC 0378-4050
11-digit product format 003784050
Labeler code 0378
Product ID 0378-4050_af4a1dc3-d150-42dc-95ab-89d579f1725a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nevirapine
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA202523
Marketing category ANDA
Marketing start 2012-05-22
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 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 RLD / RS 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.
Additional Listing Data#
Finished product Yes
Brand name base Nevirapine
Listing expiration 2027-12-31 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 0378-4050-91 Nevirapine 60 in 1 BOTTLE, PLASTIC TABLET 60 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-4050 NEVIRAPINE TABLET [MYLAN PHARMACEUTICALS INC.] 10 Current NDC, Legacy NDC, 1 package rows 20240612_c6e93829-7024-48f6-8023-da6ff27dfc0a.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.
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 0378-4050-91 00378405091 60 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91) 60 tablet 2012-05-22 0000-00-00 No No Current