Methocarbamol
- Product NDC
- 35561-211
- Requested package NDC
- 35561-211-13
- 11-digit product format
- 355610211
- Labeler code
- 35561
- Product ID
- 35561-211_49fcc548-27fe-58d0-e063-6294a90af96d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methocarbamol
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Bostal LLC
- Application
- ANDA200958
- Marketing category
- ANDA
- Marketing start
- 2018-10-09
- Substance
- METHOCARBAMOL
- Active strength
- 750 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 35561-211 | 35561-211-13 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A200958-001 | AA |
| A200958-002 | AA |
| A200958-003 | AB |
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 | 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 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200958-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2011-10-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200958-003 | METHOCARBAMOL | 1GM | TABLET / ORAL | AB | RS | 2021-12-06 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200958-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2011-10-21 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200958-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200958-002 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200958-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A200958-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200958-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200958-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A200958-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200958-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200958-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200958-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200958-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200958-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200958-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200958-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200958-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200958-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200958-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200958-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200958-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200958-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200958-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200958-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200958-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200958-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200958-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200958-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200958-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200958-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200958-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200958-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200958-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200958-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200958-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200958-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200958-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200958-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200958-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200958-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200958-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200958-001 | AA | 1 | 301d65b070ca… |
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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHOCARBAMOL | 750 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 125OD7737X | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d8f10211-f96e-4cf3-9b49-986eb51b703d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 492965be-47bc-38cf-57c4-5c5e0343abe5 | Product name | 6 | 20211028 |
| 02a01e9c-3f4e-c0ee-6542-be865127aea3 | Product name | 8 | 20190205 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 35561-211-12 | 2024-04-08 | d8f10211-f96e-4cf3-9b49-986eb51b703d |
| 35561-211-13 | 2024-04-08 | d8f10211-f96e-4cf3-9b49-986eb51b703d |
| 35561-211-12 | 2024-01-30 | d8f10211-f96e-4cf3-9b49-986eb51b703d |
| 35561-211-13 | 2024-01-30 | d8f10211-f96e-4cf3-9b49-986eb51b703d |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35561-211-12 | Methocarbamol | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 8 | |
| 35561-211-13 | Methocarbamol | 500 in 1 BOTTLE, PLASTIC | TABLET, COATED | 500 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35561-211-12 | EA - Each | 35561-211 | f812743d-b943-4715-ab07-066b446334a0 | 1 | 2019-11-12 |
| 35561-211-13 | EA - Each | 35561-211 | c5163e65-2231-4f0e-b0dd-a055c025d99b | 1 | 2019-11-12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methocarbamol | METHOCARBAMOL | Misemer Pharmaceutical | e89ae224-ed25-4ae7-e053-2a95a90a9c0e | 2026-03-18 | Warnings, Adverse reactions | 200958 ANDA200958 |
| Methocarbamol | METHOCARBAMOL | Bostal LLC | d8f10211-f96e-4cf3-9b49-986eb51b703d | 2026-02-04 | Warnings, Adverse reactions | 200958 ANDA200958 35561-211-13 35561-211 35561021113 |
| Methocarbamol | METHOCARBAMOL | Oncora Pharma, LLC | 440d6c99-8aca-af07-e063-6294a90aee3d | 2025-11-20 | Warnings, Adverse reactions | 200958 ANDA200958 |
| Methocarbamol | METHOCARBAMOL | Trifluent Pharma LLC | de2e3af9-03ab-4dc8-b480-6866474ad1bd | 2025-03-03 | Warnings, Adverse reactions | 200958 ANDA200958 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2611794 | methocarbamol 1000 MG Oral Tablet | PSN | d8f10211-f96e-4cf3-9b49-986eb51b703d | 8 |
| 197943 | methocarbamol 500 MG Oral Tablet | PSN | d8f10211-f96e-4cf3-9b49-986eb51b703d | 8 |
| 197944 | methocarbamol 750 MG Oral Tablet | PSN | d8f10211-f96e-4cf3-9b49-986eb51b703d | 8 |
| 2611794 | methocarbamol 1000 MG Oral Tablet | SCD | d8f10211-f96e-4cf3-9b49-986eb51b703d | 8 |
| 197943 | methocarbamol 500 MG Oral Tablet | SCD | d8f10211-f96e-4cf3-9b49-986eb51b703d | 8 |
| 197944 | methocarbamol 750 MG Oral Tablet | SCD | d8f10211-f96e-4cf3-9b49-986eb51b703d | 8 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 35561-211-13 | 35561021113 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (35561-211-13) | 2018-10-09 | 0000-00-00 | No | No | Current |