Home NDC 85477-101 Methocarbamol
Product NDC 85477-101
11-digit product format 854770101
Labeler code 85477
Product ID 85477-101_440d6c53-6c13-3f8d-e063-6294a90a2a2b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methocarbamol
Dosage form TABLET, COATED
Route ORAL
Labeler Oncora Pharma, LLC
Application ANDA200958
Marketing category ANDA
Marketing start 2025-11-20
Substance METHOCARBAMOL
Active strength 1000 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
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 · 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.
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 2026-08-01 22:54:32 2026-06 A200958-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2011-10-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A200958-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2011-10-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A200958-003 METHOCARBAMOL 1GM TABLET / ORAL AB RS 2021-12-06 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Methocarbamol
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 85477-101-10 Methocarbamol 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 85477-101-10 85477010110 100 TABLET, COATED in 1 BOTTLE, PLASTIC (85477-101-10) 2025-11-20 No No Current