Home NDC 0003-1964 ZERIT
Product NDC 0003-1964
11-digit product format 000031964
Labeler code 0003
Product ID 0003-1964_38a2d755-5358-43e3-b005-ab103e97789b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Stavudine
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler E.R. Squibb & Sons, L.L.C.
Application NDA020412
Marketing category NDA
Marketing start 2017-06-13
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 No
Listing certified through 2019-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0003-1964-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0003-1964-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0003-1964-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0003-1964-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0003-1964-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0003-1964-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0003-1964-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0003-1964-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0003-1964-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0003-1964-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0003-1964-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0003-1964-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020412-001 ZERIT STAVUDINE 5MG CAPSULE / ORAL 1994-06-24 N020412-002 ZERIT STAVUDINE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 N020412-003 ZERIT STAVUDINE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 N020412-004 ZERIT STAVUDINE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 N020412-005 ZERIT STAVUDINE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24
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 6 · 220 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 2026-10-15 13:18:30 2026-09 N020412-001 ZERIT 5MG CAPSULE / ORAL 1994-06-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020412-002 ZERIT 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020412-003 ZERIT 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020412-004 ZERIT 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020412-005 ZERIT 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020412-001 ZERIT 5MG CAPSULE / ORAL 1994-06-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020412-002 ZERIT 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020412-003 ZERIT 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020412-004 ZERIT 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020412-005 ZERIT 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020412-001 ZERIT 5MG CAPSULE / ORAL 1994-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020412-002 ZERIT 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020412-003 ZERIT 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020412-004 ZERIT 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020412-005 ZERIT 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020412-001 ZERIT 5MG CAPSULE / ORAL 1994-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020412-002 ZERIT 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020412-003 ZERIT 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020412-004 ZERIT 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020412-005 ZERIT 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020412-001 ZERIT 5MG CAPSULE / ORAL 1994-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020412-002 ZERIT 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020412-003 ZERIT 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020412-004 ZERIT 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020412-005 ZERIT 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020412-001 ZERIT 5MG CAPSULE / ORAL 1994-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020412-002 ZERIT 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020412-003 ZERIT 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020412-004 ZERIT 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020412-005 ZERIT 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020412-001 ZERIT 5MG CAPSULE / ORAL 1994-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020412-002 ZERIT 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020412-003 ZERIT 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020412-004 ZERIT 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020412-005 ZERIT 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020412-001 ZERIT 5MG CAPSULE / ORAL 1994-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020412-002 ZERIT 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020412-003 ZERIT 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020412-004 ZERIT 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020412-005 ZERIT 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1994-06-24 b8a1b40f171c…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded stavudine ACTIVE INGREDIENT BO9LE4QFZF ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 stavudine ACTIVE MOIETY BO9LE4QFZF ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 gelatin INACTIVE INGREDIENT 2G86QN327L ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 lactose INACTIVE INGREDIENT J2B2A4N98G ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 methylparaben INACTIVE INGREDIENT A2I8C7HI9T ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 sucrose INACTIVE INGREDIENT C151H8M554 ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 23