Methocarbamol
- Product NDC
- 68071-2563
- 11-digit product format
- 680712563
- Labeler code
- 68071
- Product ID
- 68071-2563_cff9b7a0-8611-f860-e053-2995a90a2d07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methocarbamol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040489
- Marketing category
- ANDA
- Marketing start
- 2019-08-15
- 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#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68071-2563 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 68071-2563 | 68071-2563-6 | I | Inactivated by FDA | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040489-001 | METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2003-01-29 | |
| A040489-002 | METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2003-01-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040489-001 | AA |
| A040489-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A040489-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | 2003-01-29 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A040489-002 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | 2003-01-29 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A040489-001 | AA | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A040489-002 | AA | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 3d4a2486-863e-4e9f-be3b-67882863e7d4 | 2026-07-29 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 6b9ed3a4-46d5-462e-ac93-6b959b314d77 | 2026-07-29 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | adb49cb7-8900-44dc-add0-22e2cd8235ac | 2026-07-29 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | PD-Rx Pharmaceuticals, Inc. | 0deb5368-ffdc-40fc-a97c-ba89b7a97e50 | 2026-07-21 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | 9617e2b0-4255-4542-95ca-9ee1818ca450 | 2026-06-26 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | HAWAII REPACK, INC. | 8643032a-c491-4ae4-ac46-5e0c4c79dc5b | 2026-06-26 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | cfdc0d68-00ad-44d6-b932-819cc3d5d60e | 2026-06-26 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | A-S Medication Solutions | b81a8e64-ae41-409b-94a6-b36cb50bc25d | 2026-06-26 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | HAWAII REPACK, INC. | c4744824-4c74-411d-aa8e-c63ee9d89913 | 2026-06-25 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | Preferred Pharmaceuticals Inc. | 4ef1c2c0-31e1-4f85-b645-ff47a057a994 | 2026-06-23 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | Preferred Pharmaceuticals, Inc | 425abc3b-2111-4fac-bf27-b685d1e657af | 2026-06-23 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | Direct_rx | 4c5c8933-a4b5-f9c2-e063-6294a90a6f00 | 2026-06-16 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | 5af36a83-2b36-4fe2-8c6a-61b551621421 | 2026-06-16 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | cc004f5c-d5fc-48c5-9f37-c59b9c37e113 | 2026-06-16 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | 9076b4ad-17be-4933-a975-7bf80cc92b49 | 2026-06-10 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | 3f8aed5d-ba8d-4c32-872b-08ab15240cc1 | 2026-06-10 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | St. Mary's Medical Park Pharmacy | fd8cac57-9664-1fa0-e053-6294a90af872 | 2026-06-02 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | 6466438c-4609-4554-8919-35710a1b556d | 2026-06-01 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | 33f89a57-f65d-4e99-a3a3-690ef805d869 | 2026-05-27 | Warnings, Adverse reactions | 040489 ANDA040489 |
| Methocarbamol | METHOCARBAMOL | Bryant Ranch Prepack | 6af87b4e-6507-4190-b043-a6d3b440314a | 2026-05-27 | Warnings, Adverse reactions | 040489 ANDA040489 |
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 | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2563-6 | 2025-01-30 | C162847 | 48780-1 | f386c64a-2cda-0266-e053-dadaa90a7c1a | Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only |
| 68071-2563-6 | 2023-07-17 | C162847 | 48780-1 | f386c64a-2cda-0266-e053-dadaa90a7c1a | Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only |
| 68071-2563-6 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2cda-0266-e053-dadaa90a7c1a | Methocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2563-6 | Methocarbamol | 6 in 1 BOTTLE | TABLET | 6 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2563 | METHOCARBAMOL TABLET [NUCARE PHARMACEUTICALS,INC.] | 2 | Legacy NDC, 1 package rows | 20230718_cff9b44c-618c-4beb-e053-2a95a90a24b0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197944 | methocarbamol 750 MG Oral Tablet | PSN | cff9b44c-618c-4beb-e053-2a95a90a24b0 | 2 |
| 197944 | methocarbamol 750 MG Oral Tablet | SCD | cff9b44c-618c-4beb-e053-2a95a90a24b0 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-2563-6 | 68071256306 | 6 TABLET in 1 BOTTLE (68071-2563-6) | 6 tablet | 2021-11-04 | 0000-00-00 | No | No | Current |