Meprobamate

Product NDC
62332-020
11-digit product format
623320020
Labeler code
62332
Product ID
62332-020_a2f676cd-53ae-4401-9553-a7d70c79bb0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meprobamate
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA090122
Marketing category
ANDA
Marketing start
2016-03-31
Substance
MEPROBAMATE
Active strength
400 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A090122-001MEPROBAMATEMEPROBAMATE200MGTABLET / ORALAARS2009-02-18
A090122-002MEPROBAMATEMEPROBAMATE400MGTABLET / ORALAARS2009-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090122-001AA
A090122-002AA

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 UTC2026-02A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090122-001MEPROBAMATE200MGTABLET / ORALAA2009-02-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090122-002MEPROBAMATE400MGTABLET / ORALAA2009-02-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090122-001MEPROBAMATE200MGTABLET / ORALAARS2009-02-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A090122-002MEPROBAMATE400MGTABLET / ORALAARS2009-02-18782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090122-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090122-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090122-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090122-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090122-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090122-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090122-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090122-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090122-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090122-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090122-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090122-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090122-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090122-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090122-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090122-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090122-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090122-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090122-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090122-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090122-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090122-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090122-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090122-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090122-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090122-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090122-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090122-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090122-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090122-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090122-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090122-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090122-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090122-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090122-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090122-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090122-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090122-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090122-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090122-002AA1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Meprobamate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPROBAMATE400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9I7LNY769QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197928Internal RxNorm lookup
197929Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b255bcd-0218-44f8-830b-971f5ec45276Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-020-30Meprobamate30 in 1 BOTTLETABLET307
62332-020-31Meprobamate100 in 1 BOTTLETABLET1007
62332-020-91Meprobamate1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-020-31EA - Each62332-02023a4e237-22af-4f6d-9396-eea850aff12c12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-020MEPROBAMATE TABLET [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 3 package rows20211003_3b255bcd-0218-44f8-830b-971f5ec45276.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
MEPROBAMATEMEPROBAMATEAlembic Pharmaceuticals Limiteda0891a32-105b-48bc-a246-5e179d2e7fa12023-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090122
application number: ANDA090122
MeprobamateMEPROBAMATEAlembic Pharmaceuticals Inc.3b255bcd-0218-44f8-830b-971f5ec452762021-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090122
application number: ANDA090122
ndc (product): 62332-020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197928meprobamate 200 MG Oral TabletPSN3b255bcd-0218-44f8-830b-971f5ec452767
197929meprobamate 400 MG Oral TabletPSN3b255bcd-0218-44f8-830b-971f5ec452767
197928meprobamate 200 MG Oral TabletSCD3b255bcd-0218-44f8-830b-971f5ec452767
197929meprobamate 400 MG Oral TabletSCD3b255bcd-0218-44f8-830b-971f5ec452767

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-020-306233200203030 TABLET in 1 BOTTLE (62332-020-30) 30 tablet2016-03-310000-00-00NoNoCurrent
62332-020-3162332002031100 TABLET in 1 BOTTLE (62332-020-31) 100 tablet2016-03-310000-00-00NoNoCurrent
62332-020-91623320020911000 TABLET in 1 BOTTLE (62332-020-91) 1000 tablet2016-03-310000-00-00NoNoCurrent