Meprobamate

Product NDC
52549-4148
11-digit product format
525494148
Labeler code
52549
Product ID
52549-4148_a1a2d874-5b9c-4f21-bb21-8757f2468b2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meprobamate
Dosage form
TABLET
Route
ORAL
Labeler
Taro Pharmaceutical Industries Ltd.
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
E
Listing certified through
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52549-4148DDiscontinued by firm2026-08-03
excluded packagepackage52549-414852549-4148-1DDiscontinued by firm2026-08-03
excluded packagepackage52549-414852549-4148-3DDiscontinued by firm2026-08-03
excluded packagepackage52549-414852549-4148-6DDiscontinued 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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52549-4148-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52549-4148-6DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52549-4148-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52549-4148-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52549-4148-6IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52549-4148-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52549-4148-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52549-4148-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52549-4148-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52549-4148-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52549-4148-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52549-4148-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52549-4148-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52549-4148-6IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52549-4148-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52549-4148-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52549-4148-6IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52549-4148-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52549-4148-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52549-4148-6IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52549-4148-3IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52549-4148-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52549-4148-6IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52549-4148-3IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52549-4148-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52549-4148-6IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52549-4148-3IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52549-4148-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52549-4148-6IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52549-4148-3IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52549-4148-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52549-4148-6IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52549-4148-3IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52549-4148-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52549-4148-6IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52549-4148-3IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52549-4148-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52549-4148-6IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52549-4148-3IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52549-4148-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52549-4148-6IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52549-4148-3IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52549-4148-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52549-4148-6IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52549-4148-3IInactivated by FDA1332a3947898…d4bfe170f9cd…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MeprobamateACTIVE INGREDIENT9I7LNY769QMEPROBAMATE TABLET [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
MeprobamateACTIVE MOIETY9I7LNY769QMEPROBAMATE TABLET [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMEPROBAMATE TABLET [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MEPROBAMATE TABLET [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MEPROBAMATE TABLET [TARO PHARMACEUTICAL INDUSTRIES LTD.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APMEPROBAMATE TABLET [TARO PHARMACEUTICAL INDUSTRIES LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52549-4148MEPROBAMATE TABLET [TARO PHARMACEUTICAL INDUSTRIES LTD.]1Legacy NDC20110816_e9aa3d4c-f2e9-4ca9-b563-85fac4024539.zip