Home NDC 61442-470 Nevirapine
Product NDC 61442-470
11-digit product format 614420470
Labeler code 61442
Product ID 61442-470_2e32fb7f-e3f5-6415-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nevirapine
Dosage form TABLET, COATED
Route ORAL
Labeler Carlsbad Technology, Inc.
Application ANDA203176
Marketing category ANDA
Marketing start 2016-01-01
Marketing end 0000-00-00
Substance NEVIRAPINE
Active strength 200 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 E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61442-470-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61442-470-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61442-470-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61442-470-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61442-470-60 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61442-470-60 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61442-470-60 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61442-470-60 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61442-470-60 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61442-470-60 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61442-470-60 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61442-470-60 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 61442-470-60 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 61442-470-60 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 61442-470-60 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61442-470-60 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A203176-001 NEVIRAPINE NEVIRAPINE 200MG TABLET / ORAL 2012-05-22
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 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203176-001 NEVIRAPINE 200MG TABLET / ORAL 2012-05-22 e64feba35796…
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 61442-470-60 2022-03-22 C162847 48780-1 9d75b9cf-dadb-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use NEVIRAPINE tablets, USP safely and effectively. See full prescribing information for NEVIRAPINE tablets, USP. NEVIRAPINE tablets, USP 200 mg, for oral use Initial U.S. Approval: 1996 61442-470-60 2020-01-31 C162847 48780-1 9d75b9cf-dadb-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use NEVIRAPINE tablets, USP safely and effectively. See full prescribing information for NEVIRAPINE tablets, USP. NEVIRAPINE tablets, USP 200 mg, for oral use Initial U.S. Approval: 1996