Home NDC 31722-515 Stavudine
Product NDC 31722-515
11-digit product format 317220515
Labeler code 31722
Product ID 31722-515_47401c88-8cae-4352-9942-94fbc43e856a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Stavudine
Dosage form CAPSULE
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA078957
Marketing category ANDA
Marketing start 2008-12-29
Marketing end 0000-00-00
Substance STAVUDINE
Active strength 15 mg/1
Pharmacologic classes Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
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 2 · 76 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 31722-515-60 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 31722-515-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 31722-515-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 31722-515-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 31722-515-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 31722-515-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 31722-515-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 31722-515-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 31722-515-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 31722-515-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 31722-515-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 31722-515-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 31722-515-10 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 31722-515-60 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 31722-515-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 31722-515-10 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 31722-515-10 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 31722-515-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 31722-515-60 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 31722-515-10 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 31722-515-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 31722-515-60 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 31722-515-10 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 31722-515-01 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 31722-515-60 I Inactivated by FDA bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078957-001 STAVUDINE STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 A078957-002 STAVUDINE STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 A078957-003 STAVUDINE STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 A078957-004 STAVUDINE STAVUDINE 40MG CAPSULE / ORAL 2008-12-29
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 5 · 172 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 2026-09-14 22:38:34 2026-08 A078957-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078957-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078957-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078957-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078957-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078957-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078957-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078957-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078957-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078957-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078957-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078957-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078957-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078957-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078957-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078957-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078957-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078957-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078957-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078957-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078957-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078957-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078957-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078957-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078957-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078957-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078957-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078957-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078957-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078957-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078957-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078957-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078957-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078957-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078957-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078957-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078957-001 STAVUDINE 15MG CAPSULE / ORAL 2008-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078957-002 STAVUDINE 20MG CAPSULE / ORAL 2008-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078957-003 STAVUDINE 30MG CAPSULE / ORAL 2008-12-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078957-004 STAVUDINE 40MG CAPSULE / ORAL 2008-12-29 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded STAVUDINE ACTIVE INGREDIENT BO9LE4QFZF STAVUDINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] 2 STAVUDINE ACTIVE MOIETY BO9LE4QFZF STAVUDINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK STAVUDINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U STAVUDINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L STAVUDINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 STAVUDINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J STAVUDINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 STAVUDINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP STAVUDINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] 2