Home NDC 68788-8880-6 METHOCARBAMOL
Product NDC 68788-8880
Requested package NDC 68788-8880-6
11-digit product format 687888880
Labeler code 68788
Product ID 68788-8880_5a48be27-5069-40f3-85de-86f248ae232f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHOCARBAMOL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA203550
Marketing category ANDA
Marketing start 2025-06-02
Substance METHOCARBAMOL
Active strength 500 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 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203550-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2017-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203550-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2017-02-08 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base METHOCARBAMOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOCARBAMOL 500 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 197943 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 68788-8880-3 METHOCARBAMOL 30 in 1 BOTTLE TABLET, FILM COATED 30 1 68788-8880-6 METHOCARBAMOL 60 in 1 BOTTLE TABLET, FILM COATED 60 1 68788-8880-9 METHOCARBAMOL 90 in 1 BOTTLE TABLET, FILM COATED 90 1
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 Sample Exclude flag Status 68788-8880-6 68788888006 60 TABLET, FILM COATED in 1 BOTTLE (68788-8880-6) 2025-06-02 No No Current