Home NDC 68788-8822 Methocarbamol
Product NDC 68788-8822
11-digit product format 687888822
Labeler code 68788
Product ID 68788-8822_eed9ebd1-c243-4e82-bf4e-5fec370e722e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methocarbamol
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA090200
Marketing category ANDA
Marketing start 2025-02-10
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 44 .
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 A090200-001 METHOCARBAMOL METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 A090200-002 METHOCARBAMOL METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06
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 · 88 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 2026-10-15 13:18:30 2026-09 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090200-001 METHOCARBAMOL 500MG TABLET / ORAL AA 2009-11-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090200-002 METHOCARBAMOL 750MG TABLET / ORAL AA 2009-11-06 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8822 METHOCARBAMOL TABLET [PREFERRED PHARMACEUTICALS INC.] 1 Current NDC, 7 package rows 20250212_eed9ebd1-c243-4e82-bf4e-5fec370e722e.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 2 of 2 · 24 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8822-1 68788882201 100 TABLET in 1 BOTTLE (68788-8822-1) 100 tablet 2025-02-10 No No Current 68788-8822-2 68788882202 20 TABLET in 1 BOTTLE (68788-8822-2) 20 tablet 2025-02-10 No No Current 68788-8822-3 68788882203 30 TABLET in 1 BOTTLE (68788-8822-3) 30 tablet 2025-02-10 No No Current 68788-8822-4 68788882204 40 TABLET in 1 BOTTLE (68788-8822-4) 40 tablet 2025-02-10 No No Current 68788-8822-6 68788882206 60 TABLET in 1 BOTTLE (68788-8822-6) 60 tablet 2025-02-10 No No Current 68788-8822-8 68788882208 120 TABLET in 1 BOTTLE (68788-8822-8) 120 tablet 2025-02-10 No No Current 68788-8822-9 68788882209 90 TABLET in 1 BOTTLE (68788-8822-9) 90 tablet 2025-02-10 No No Current