ALBENZA

Product NDC
76413-145
11-digit product format
764130145
Labeler code
76413
Product ID
76413-145_f91924ce-6feb-42e5-9489-68f11d7acb77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albendazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Central Texas Community Health Centers
Application
NDA020666
Marketing category
NDA
Marketing start
1996-06-11
Marketing end
0000-00-00
Substance
ALBENDAZOLE
Active strength
200 mg/1
Pharmacologic classes
Anthelmintic [EPC],Cytochrome P450 1A 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 productproduct76413-145IInactivated by FDA2026-08-03
excluded packagepackage76413-14576413-145-01IInactivated by FDA2026-08-03
excluded packagepackage76413-14576413-145-02IInactivated by FDA2026-08-03

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 packagepackage76413-145-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-145-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-145-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-145-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-145-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-145-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-145-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-145-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-145-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-145-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-145-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-145-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-145-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-145-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-145-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-145-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-145-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-145-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-145-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-145-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76413-145-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76413-145-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76413-145-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76413-145-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76413-145-028af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76413-145-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76413-145-02834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76413-145-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76413-145-021332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76413-145-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76413-145-02fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76413-145-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76413-145-0286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76413-145-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76413-145-02bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76413-145-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage76413-145-028dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage76413-145-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76413-145-02e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76413-145-01e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020666-001ALBENZAALBENDAZOLE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-11

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020666-001ALBENZA200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-113f01610625f2…
2019-09-15 20:21 UTC2019-09N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N020666-001ALBENZA200MGTABLET / ORALABRLD, RS1996-06-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020666-001ALBENZA200MGTABLET / ORALRLD1996-06-11cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020666-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020666-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020666-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020666-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020666-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020666-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020666-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020666-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020666-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020666-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020666-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020666-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020666-001AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b0e27303-91cd-2fd1-e9ec-fbe22a3c3f49Product name820250325

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-145-01ALBENZA1 in 1 BOTTLETABLET, FILM COATED11
76413-145-02ALBENZA2 in 1 BOTTLETABLET, FILM COATED21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-145ALBENZA (ALBENDAZOLE) TABLET, FILM COATED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 2 package rows20170909_62a3f663-9e76-47f6-b089-54e4db01f697.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlbendazoleALBENDAZOLEAmneal Pharmaceuticals of New York LLC06b5eefc-0b95-4862-b9b6-770063f2adf02019-09-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 020666
application number: NDA020666
ALBENZAALBENDAZOLEAmneal Pharmaceuticals LLC1977a867-0ee1-44c0-8da3-fe59c48699f52019-09-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 020666
application number: NDA020666

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199672albendazole 200 MG Oral TabletPSN62a3f663-9e76-47f6-b089-54e4db01f6971
211148Albenza 200 MG Oral TabletPSN62a3f663-9e76-47f6-b089-54e4db01f6971
211148albendazole 200 MG Oral Tablet [Albenza]SBD62a3f663-9e76-47f6-b089-54e4db01f6971
199672albendazole 200 MG Oral TabletSCD62a3f663-9e76-47f6-b089-54e4db01f6971
211148Albenza 200 MG Oral TabletSY62a3f663-9e76-47f6-b089-54e4db01f6971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-145-01764130145011 in 1 BOTTLEHistorical
76413-145-02764130145022 in 1 BOTTLEHistorical