Home NDC 69097-974 Meprobamate
Product NDC 69097-974
11-digit product format 690970974
Labeler code 69097
Product ID 69097-974_1fe09b66-c58f-4d50-8932-96f52bda4bcb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meprobamate
Dosage form TABLET
Route ORAL
Labeler Cipla USA Inc.
Application ANDA040797
Marketing category ANDA
Marketing start 2021-06-07
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 A040797-001 MEPROBAMATE MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 A040797-002 MEPROBAMATE MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27
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 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040797-001 MEPROBAMATE 200MG TABLET / ORAL AA 2008-02-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040797-002 MEPROBAMATE 400MG TABLET / ORAL AA 2008-02-27 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 2027-12-31 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 69097-974-07 Meprobamate 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-974 MEPROBAMATE TABLET [CIPLA USA INC.] 1 Current NDC, Legacy NDC, 1 package rows 20210620_17d814e2-b277-4dce-8615-e7fd7cab773f.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 · 1 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 69097-974-07 69097097407 100 TABLET in 1 BOTTLE (69097-974-07) 100 tablet 2021-06-07 0000-00-00 No No Current