Home NDC 35561-349 Methocarbamol
Product NDC 35561-349
11-digit product format 355610349
Labeler code 35561
Product ID 35561-349_49fcc548-27fe-58d0-e063-6294a90af96d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methocarbamol
Dosage form TABLET, COATED
Route ORAL
Labeler Bostal LLC
Application ANDA200958
Marketing category ANDA
Marketing start 2022-07-16
Substance METHOCARBAMOL
Active strength 1000 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base Methocarbamol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOCARBAMOL 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 125OD7737X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197943 Internal RxNorm lookup 197944 Internal RxNorm lookup 2611794 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 35561-349-12 Methocarbamol 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 8 35561-349-13 Methocarbamol 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35561-349 METHOCARBAMOL TABLET, COATED [AUSTARPHARMA LLC] 7 Current NDC, 2 package rows 20240807_d8f10211-f96e-4cf3-9b49-986eb51b703d.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 Sample Exclude flag Status 35561-349-12 35561034912 100 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-349-12) 2022-07-16 No No Current 35561-349-13 35561034913 500 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-349-13) 2022-07-16 No No Current