Home NDC 0404-9992 METHOCARBAMOL
Product NDC 0404-9992
11-digit product format 004049992
Labeler code 0404
Product ID 0404-9992_04e87c62-491d-4c9a-87b5-7e0794109765
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methocarbamol
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Henry Schein, Inc
Application ANDA206128
Marketing category ANDA
Marketing start 2023-04-06
Marketing end 2027-04-30
Substance METHOCARBAMOL
Active strength 1000 mg/10mL
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag No
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206128-001 METHOCARBAMOL METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206128-001 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 · 43 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 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206128-001 METHOCARBAMOL 1GM/10ML (100MG/ML) SOLUTION / IM-IV AP 2016-05-27 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 A206128-001 AP 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206128-001 AP 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206128-001 AP 1 a50c72e98297…
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 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOCARBAMOL 1000 mg/10mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-9992-10 METHOCARBAMOL 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 3 0404-9992-10 METHOCARBAMOL 1 in 1 BAG INJECTION, SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9992 METHOCARBAMOL INJECTION, SOLUTION [HENRY SCHEIN, INC] 2 Current NDC, 2 package rows 20240719_d48d76af-b55a-4908-95ff-e7de615c0513.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0404-9992-10 00404999210 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9992-10) / 10 mL in 1 VIAL, SINGLE-DOSE 2023-04-06 2027-04-30 No No Historical