Meprobamate

Product NDC
51672-4148
Requested package NDC
51672-4148-6
11-digit product format
516724148
Labeler code
51672
Product ID
51672-4148_3ca1984e-69f7-4fc5-9184-3843d737e518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meprobamate
Dosage form
TABLET
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA200998
Marketing category
ANDA
Marketing start
2011-05-23
Marketing end
0000-00-00
Substance
MEPROBAMATE
Active strength
400 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51672-414851672-4148-6DDiscontinued by firm2026-08-03

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 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51672-414851672-4148-6DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200998-001MEPROBAMATEMEPROBAMATE200MGTABLET / ORAL2011-05-23
A200998-002MEPROBAMATEMEPROBAMATE400MGTABLET / ORAL2011-05-23

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200998-001MEPROBAMATE200MGTABLET / ORAL2011-05-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A200998-002MEPROBAMATE400MGTABLET / ORAL2011-05-23782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b9268013-e5ec-7d19-0af8-fce7c9afbdb1Product name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MeprobamateACTIVE INGREDIENT9I7LNY769QMEPROBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
MeprobamateACTIVE MOIETY9I7LNY769QMEPROBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMEPROBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30MEPROBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MEPROBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2MEPROBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
starch, cornINACTIVE INGREDIENTO8232NY3SJMEPROBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3
stearic acidINACTIVE INGREDIENT4ELV7Z65APMEPROBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4148MEPROBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]4Legacy NDC20190208_4a9ad4f6-6826-4cb8-a097-2d2ea2c91d8b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4148-65167241480630 TABLET in 1 BOTTLE (51672-4148-6) 30 tablet2011-05-230000-00-00NoNoCurrent