Home NDC 71093-140 METHOCARBAMOL
Product NDC 71093-140
11-digit product format 710930140
Labeler code 71093
Product ID 71093-140_f952d2bf-7825-4a85-9d59-592cbe28d7fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHOCARBAMOL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ACI Healthcare USA, Inc.
Application ANDA203550
Marketing category ANDA
Marketing start 2017-02-08
Marketing end 0000-00-00
Substance METHOCARBAMOL
Active strength 500 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71093-140-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71093-140-04 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71093-140-05 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71093-140-04 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71093-140-05 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71093-140-04 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71093-140-05 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71093-140-04 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71093-140-05 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71093-140-04 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71093-140-05 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71093-140-04 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71093-140-05 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71093-140-04 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71093-140-05 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71093-140-04 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71093-140-05 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71093-140-04 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A203550-001 METHOCARBAMOL METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 A203550-002 METHOCARBAMOL METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08
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 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71093-140-04 METHOCARBAMOL 100 in 1 BOTTLE TABLET, FILM COATED 100 8 71093-140-05 METHOCARBAMOL 500 in 1 BOTTLE TABLET, FILM COATED 500 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71093-140 METHOCARBAMOL TABLET, FILM COATED [ACI HEALTHCARE USA, INC.] 8 Legacy NDC, 2 package rows 20231222_b19fe4cb-7a72-4668-8981-db7a1f4fa5a1.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 Marketing start Marketing end Sample Exclude flag Status 71093-140-04 71093014004 100 TABLET, FILM COATED in 1 BOTTLE (71093-140-04) 2017-02-08 0000-00-00 No No Current 71093-140-05 71093014005 500 TABLET, FILM COATED in 1 BOTTLE (71093-140-05) 2017-02-08 0000-00-00 No No Current