Methocarbamol
- Product NDC
- 35573-414
- Requested package NDC
- 35573-414-02
- 11-digit product format
- 355730414
- Labeler code
- 35573
- Product ID
- 35573-414_c3110908-1965-1576-e053-2995a90a524d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methocarbamol
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Burel Pharmaceuticals, Inc.
- Application
- ANDA209312
- Marketing category
- ANDA
- Marketing start
- 2019-09-30
- Marketing end
- 0000-00-00
- Substance
- METHOCARBAMOL
- Active strength
- 750 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 35573-414 | 35573-414-02 | D | Discontinued by firm | 2026-08-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 35573-414 | 35573-414-02 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 35573-414 | 35573-414-02 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209312-001 | METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 |
| A209312-002 | METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209312-001 | AA |
| A209312-002 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2018-05-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209312-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | RS | 2018-05-07 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A209312-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | RS | 2018-05-07 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209312-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209312-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209312-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209312-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209312-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209312-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209312-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209312-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209312-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209312-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209312-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209312-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209312-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209312-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209312-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209312-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209312-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209312-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209312-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209312-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209312-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209312-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209312-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209312-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209312-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209312-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209312-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A209312-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209312-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209312-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209312-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A209312-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209312-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A209312-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A209312-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209312-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A209312-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A209312-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209312-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A209312-002 | AA | 1 | 782e0a99824c… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35573-414-02 | EA - Each | 35573-414 | cf6ced75-a7bb-4e28-a905-8774cf904f29 | 1 | 2019-12-10 |
| 35573-414-04 | EA - Each | 35573-414 | a0b3aef4-e181-43af-87b7-660db0ecca50 | 1 | 2019-12-10 |
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 TABLETS | REMEDYREPACK INC. | 52b20439-6bf4-435e-817a-c3b3fc70846a | 2026-07-10 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | REMEDYREPACK INC. | 37767123-8b72-4e1f-b00d-ff3305e9923f | 2026-07-10 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Unit Dose Solutions, Inc. | 561ae476-9e1f-038a-e063-6394a90aa5c7 | 2026-07-08 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Granules Pharmaceuticals Inc. | 6f0d3966-962d-fa7c-e053-2a91aa0a8e3c | 2026-07-07 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Bryant Ranch Prepack | 65c460f6-6470-41ff-abb4-d9d54ecc52f7 | 2026-07-06 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | St. Mary's Medical Park Pharmacy | 7d4dd78a-f902-6ff2-e053-2991aa0ac7d7 | 2026-06-26 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Preferred Pharmaceuticals Inc. | 43f83b87-e169-46fe-98bd-6af373595bd3 | 2026-06-23 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Preferred Pharmaceuticals Inc. | e03878d3-d780-4e7f-b828-20ac2a109933 | 2026-06-23 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Coupler LLC | 52b87514-e6e0-ab57-e063-6394a90a6b23 | 2026-05-26 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | NuCare Pharmaceuticals,Inc. | 71c21226-cd96-33ed-e053-2995a90a5269 | 2026-05-22 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | St. Mary's Medical Park Pharmacy | faa81ad3-2bd2-d637-e053-6294a90a2d36 | 2026-05-10 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Proficient Rx LP | 23163bc1-dec7-41f6-baed-eedebfd6be7e | 2026-05-01 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | REMEDYREPACK INC. | 1dc3a5b1-c83b-406b-a59d-ce8075e4ccf9 | 2026-04-28 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Advanced Rx of Tennessee, LLC | 4de118fe-bd8e-6cc4-e063-6394a90a1320 | 2026-03-25 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Advanced Rx of Tennessee, LLC | 4cefe51c-d824-a862-e063-6394a90a7717 | 2026-03-13 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Redpharm Drug | 44f264fd-bf40-bed9-e063-6294a90ac44a | 2026-03-05 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | NuCare Pharmaceuticals,Inc. | 72f36d28-15d2-30f6-e053-2a91aa0ad1ce | 2026-01-30 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Northwind Health Company, LLC | f2b4ed95-0469-393a-e053-2a95a90a98ed | 2026-01-19 | Warnings, Adverse reactions | 209312 ANDA209312 |
| METHOCARBAMOL | METHOCARBAMOL | DIRECT RX | 31508051-c9cb-149b-e054-00144ff88e88 | 2026-01-08 | Warnings, Adverse reactions | 209312 ANDA209312 |
| Methocarbamol | METHOCARBAMOL TABLETS | Northwind Health Company, LLC | f2b4ed5f-3489-9ee4-e053-2995a90a25f0 | 2026-01-01 | Warnings, Adverse reactions | 209312 ANDA209312 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 35573-414-02 | 35573041402 | 100 TABLET, COATED in 1 BOTTLE (35573-414-02) | 2019-09-30 | 0000-00-00 | No | No | Current |