ZERIT

Product NDC
53808-0656
11-digit product format
538080656
Labeler code
53808
Product ID
53808-0656_66893c23-b206-4107-ad2b-1af596b4c5c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
stavudine
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020412
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
STAVUDINE
Active strength
20 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
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-0656IInactivated by FDA2026-10-05
excluded packagepackage53808-065653808-0656-1IInactivated by FDA2026-10-05

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 · 44 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 packagepackage53808-0656-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-0656-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-0656-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-0656-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-0656-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-0656-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-0656-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-0656-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-0656-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-0656-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-0656-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-0656-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-0656-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-0656-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-0656-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-0656-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-0656-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-0656-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-0656-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-0656-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-0656-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53808-0656-1110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020412-001ZERITSTAVUDINE5MGCAPSULE / ORAL1994-06-24
N020412-002ZERITSTAVUDINE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24
N020412-003ZERITSTAVUDINE20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24
N020412-004ZERITSTAVUDINE30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24
N020412-005ZERITSTAVUDINE40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020412-001ZERIT5MGCAPSULE / ORAL1994-06-2484e616aacf4f…
2026-09-14 22:38:342026-08N020412-002ZERIT15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2484e616aacf4f…
2026-09-14 22:38:342026-08N020412-003ZERIT20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2484e616aacf4f…
2026-09-14 22:38:342026-08N020412-004ZERIT30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2484e616aacf4f…
2026-09-14 22:38:342026-08N020412-005ZERIT40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2484e616aacf4f…
2026-08-18 06:07:402026-07N020412-001ZERIT5MGCAPSULE / ORAL1994-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020412-002ZERIT15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020412-003ZERIT20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020412-004ZERIT30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24caaa826d4ba7…
2026-08-18 06:07:402026-07N020412-005ZERIT40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020412-001ZERIT5MGCAPSULE / ORAL1994-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020412-002ZERIT15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020412-003ZERIT20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020412-004ZERIT30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020412-005ZERIT40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020412-001ZERIT5MGCAPSULE / ORAL1994-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020412-002ZERIT15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020412-003ZERIT20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020412-004ZERIT30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020412-005ZERIT40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020412-001ZERIT5MGCAPSULE / ORAL1994-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020412-002ZERIT15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020412-003ZERIT20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020412-004ZERIT30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020412-005ZERIT40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020412-001ZERIT5MGCAPSULE / ORAL1994-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020412-002ZERIT15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020412-003ZERIT20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020412-004ZERIT30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020412-005ZERIT40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020412-001ZERIT5MGCAPSULE / ORAL1994-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020412-002ZERIT15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020412-003ZERIT20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020412-004ZERIT30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020412-005ZERIT40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020412-001ZERIT5MGCAPSULE / ORAL1994-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020412-002ZERIT15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020412-003ZERIT20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020412-004ZERIT30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020412-005ZERIT40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1994-06-2403ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N020412-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020412-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020412-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020412-005AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020412-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020412-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020412-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020412-005AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020412-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020412-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020412-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020412-005AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020412-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020412-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020412-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020412-005AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f7bbe6f-8bb8-eee9-cb0e-a5f4e0b695d8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0656-12019-10-21C16284748780-1956f9ecf-d1ac-621f-e053-dbdaa90a74adZERIT ® (stavudine) Capsules ZERIT ® (stavudine) for Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0656-1ZERIT30 in 1 BLISTER PACKCAPSULE, GELATIN COATED303

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0656ZERIT (STAVUDINE) CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3Legacy NDC, 1 package rows20100813_8bb73c56-74cb-4602-b9a3-57bd1082b434.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313108stavudine 20 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
313109stavudine 30 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
313110stavudine 40 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
152942Zerit 20 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
152943Zerit 30 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
152944Zerit 40 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
152942stavudine 20 MG Oral Capsule [Zerit]SBD8bb73c56-74cb-4602-b9a3-57bd1082b4343
152943stavudine 30 MG Oral Capsule [Zerit]SBD8bb73c56-74cb-4602-b9a3-57bd1082b4343
152944stavudine 40 MG Oral Capsule [Zerit]SBD8bb73c56-74cb-4602-b9a3-57bd1082b4343
313108stavudine 20 MG Oral CapsuleSCD8bb73c56-74cb-4602-b9a3-57bd1082b4343
313109stavudine 30 MG Oral CapsuleSCD8bb73c56-74cb-4602-b9a3-57bd1082b4343
313110stavudine 40 MG Oral CapsuleSCD8bb73c56-74cb-4602-b9a3-57bd1082b4343
313108D4T 20 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152942D4T 20 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
313109D4T 30 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152943D4T 30 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
313110D4T 40 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152944D4T 40 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
313108DHT 20 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152942DHT 20 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
313109DHT 30 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152943DHT 30 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
313110DHT 40 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152944DHT 40 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152942Zerit 20 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152943Zerit 30 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152944Zerit 40 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0656-15380806560130 in 1 BLISTER PACKHistorical