Home NDC 65862-057 Nevirapine
Product NDC 65862-057
11-digit product format 658620057
Labeler code 65862
Product ID 65862-057_fd37e474-7411-4466-bf46-36fc74ef6684
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nevirapine
Dosage form SUSPENSION
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077702
Marketing category ANDA
Marketing start 2012-05-22
Substance NEVIRAPINE HEMIHYDRATE
Active strength 50 mg/5mL
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 A077702-001 NEVIRAPINE NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 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 A077702-001 AA
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 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA RS 2012-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 2012-05-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077702-001 NEVIRAPINE 50MG/5ML SUSPENSION / ORAL AA 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEVIRAPINE HEMIHYDRATE 50 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B7XF2TD73C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311943 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 65862-057-11 Nevirapine 100 mL in 1 BOTTLE SUSPENSION 100 12 65862-057-24 Nevirapine 240 mL in 1 BOTTLE SUSPENSION 240 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-057 NEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED] 12 Current NDC, Legacy NDC, 2 package rows 20240921_8dfe86aa-ea5d-48d2-94a8-1a5506055d70.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 65862-057-11 65862005711 100 mL in 1 BOTTLE (65862-057-11) 100 ml 2012-05-22 0000-00-00 No No Current 65862-057-24 65862005724 240 mL in 1 BOTTLE (65862-057-24) 240 ml 2012-05-22 0000-00-00 No No Current