Home NDC 71288-716 Methocarbamol
Product NDC 71288-716
11-digit product format 712880716
Labeler code 71288
Product ID 71288-716_9e2c879f-7485-4071-ad3b-c773985048fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methocarbamol
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA211504
Marketing category ANDA
Marketing start 2018-12-17
Substance METHOCARBAMOL
Active strength 100 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211504-001 METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211504-001 AP
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 2 · 41 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 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211504-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2018-10-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methocarbamol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOCARBAMOL 100 mg/mL
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 238175 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 71288-716-10 Methocarbamol 25 in 1 CARTON INJECTION, SOLUTION 25 3 71288-716-11 Methocarbamol 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-716 METHOCARBAMOL INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 3 Current NDC, Legacy NDC, 2 package rows 20210324_b60000fc-e99b-4994-9d36-3907e0da9e06.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71288-716-10 71288071610 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-716-10) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-716-11) 2018-12-17 0000-00-00 No No Current 71288-716-11 71288071611 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical