Home NDC 61919-627-90 METHOCARBAMOL
Product NDC 61919-627
Requested package NDC 61919-627-90
11-digit product format 619190627
Labeler code 61919
Product ID 61919-627_87388b8c-daa4-3fbb-e053-2a91aa0a3e9b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHOCARBAMOL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DirectRX
Application ANDA200958
Marketing category ANDA
Marketing start 2015-01-01
Marketing end 0000-00-00
Substance METHOCARBAMOL
Active strength 750 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200958-001 METHOCARBAMOL METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 A200958-002 METHOCARBAMOL METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 A200958-003 METHOCARBAMOL METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 115 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 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 103 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 61919-627-90 METHOCARBAMOL 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-627 METHOCARBAMOL TABLET, FILM COATED METHOCARBAMOL TABLET, COATED METHOCARBAMOL TABLET [DIRECTRX] 4 Legacy NDC, 1 package rows 20190424_270b68a6-1469-190d-e054-00144ff8d46c.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 · 4 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 61919-627-90 61919062790 90 TABLET, FILM COATED in 1 BOTTLE (61919-627-90) 2015-01-01 0000-00-00 No No Current