FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii9I7LNY769Q
Rxcui197928, 197929

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

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