nevirapine

Product NDC
69097-233
11-digit product format
690970233
Labeler code
69097
Product ID
69097-233_d8c3e274-100e-4526-84a2-ef541b415d4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nevirapine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA207684
Marketing category
ANDA
Marketing start
2017-08-03
Marketing end
0000-00-00
Substance
NEVIRAPINE HEMIHYDRATE
Active strength
50 mg/5mL
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
2019-12-31
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 productproduct69097-233DDiscontinued by firm2026-08-17
excluded packagepackage69097-23369097-233-44DDiscontinued by firm2026-08-17
excluded packagepackage69097-23369097-233-46DDiscontinued 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 2 · 63 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 packagepackage69097-233-46d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69097-233-44d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69097-233-46f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69097-233-44f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69097-233-462ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69097-233-442ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69097-233-46a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69097-233-44a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69097-233-46cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69097-233-44cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69097-233-46cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69097-233-44cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69097-233-46302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69097-233-44302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69097-233-46ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69097-233-44ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69097-233-460efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69097-233-440efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69097-233-46ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69097-233-44ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69097-233-46367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69097-233-44367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69097-233-46557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69097-233-44557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69097-233-468af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69097-233-448af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69097-233-46834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69097-233-44834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69097-233-461332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69097-233-441332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69097-233-46fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69097-233-44fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69097-233-4686f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69097-233-4486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69097-233-46bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69097-233-44bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69097-233-468dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69097-233-448dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69097-233-46e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69097-233-44e2bbac7714bc…27bdfed8d636…

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
A207684-001NEVIRAPINENEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207684-001AA

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 06:07:402026-07A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-033f01610625f2…
2019-09-15 20:21 UTC2019-09A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207684-001NEVIRAPINE50MG/5MLSUSPENSION / ORALAA2017-08-03e64feba35796…

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 06:07:402026-07A207684-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207684-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207684-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207684-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207684-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207684-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207684-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207684-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207684-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207684-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207684-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207684-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207684-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207684-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207684-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207684-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207684-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207684-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207684-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207684-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207684-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207684-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A207684-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207684-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207684-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207684-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A207684-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207684-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207684-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207684-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207684-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207684-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207684-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207684-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207684-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207684-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207684-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207684-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207684-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207684-001AA1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-233NEVIRAPINE SUSPENSION [CIPLA USA INC.]6Legacy NDC20181218_d1e92221-5e02-4ed9-b53e-d83bbbd07944.zip