Home NDC 46708-019 MEPROBAMATE
Product NDC 46708-019
11-digit product format 467080019
Labeler code 46708
Product ID 46708-019_8c5c7ad8-a128-4243-bd03-0e7057295b3f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MEPROBAMATE
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA090122
Marketing category ANDA
Marketing start 2013-07-23
Substance MEPROBAMATE
Active strength 200 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090122-001 MEPROBAMATE MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 A090122-002 MEPROBAMATE MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA 2009-02-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA 2009-02-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090122-001 MEPROBAMATE 200MG TABLET / ORAL AA RS 2009-02-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090122-002 MEPROBAMATE 400MG TABLET / ORAL AA RS 2009-02-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base MEPROBAMATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEPROBAMATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9I7LNY769Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197928 Internal RxNorm lookup 197929 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-019-30 MEPROBAMATE 30 in 1 BOTTLE TABLET 30 3 46708-019-71 MEPROBAMATE 100 in 1 BOTTLE TABLET 100 3 46708-019-91 MEPROBAMATE 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-019 MEPROBAMATE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 3 package rows 20230111_a0891a32-105b-48bc-a246-5e179d2e7fa1.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46708-019-30 46708001930 30 TABLET in 1 BOTTLE (46708-019-30) 30 tablet 2013-07-23 0000-00-00 No No Current 46708-019-71 46708001971 100 TABLET in 1 BOTTLE (46708-019-71) 100 tablet 2013-07-23 0000-00-00 No No Current 46708-019-91 46708001991 1000 TABLET in 1 BOTTLE (46708-019-91) 1000 tablet 2013-07-23 0000-00-00 No No Current