Prescription drug · ANDA
Methocarbamol Tablets, USP, 500 mg NDC 10135-722
methocarbamol · Methocarbamol 500 mg/1 · Tablet, Film coated · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-722-01 | 10135072201 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-722-01)Marketed from Dec 9, 2021 | |
| 10135-722-05 | 10135072205 | 500 TABLET, FILM COATED in 1 BOTTLE (10135-722-05)Marketed from Dec 9, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Methocarbamol Tablets, USP, 500 mg
- Generic name (nonproprietary)
- methocarbamol
- Active ingredients
- Methocarbamol — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212623
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 10135-722_441fa8ee-c4b7-d58f-e063-6394a90a3229SPL ID 441fa8ee-c4b7-d58f-e063-6394a90a3229SPL set ID d2e38ac9-1cf3-14ca-e053-2a95a90a8522RxCUI 197943, 197944UNII 125OD7737X
- Pharmacologic class
- Muscle Relaxant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N410135072201followed by a unit qualifier and the quantityPackage 10135-0722-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Methocarbamol Tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212623
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Methocarbamol Tablets, USP, 750 mgmethocarbamol | Methocarbamol 750 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-521 |
| Methocarbamol Tablets, USP, 750 mgmethocarbamol | Methocarbamol 750 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2488 |
| Methocarbamol Tablets, USP, 500 mgmethocarbamol | Methocarbamol 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2487 |
| Methocarbamol | Methocarbamol 500 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-722 |
| Methocarbamol | Methocarbamol 750 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-723 |
| Methocarbamol Tablets, USP, 750 mgmethocarbamol | Methocarbamol 750 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-723 |
| Methocarbamol Tablets, USP, 500 mgmethocarbamol | Methocarbamol 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-481 |
| Methocarbamol Tablets, USP, 500 mgmethocarbamol | Methocarbamol 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-499 |
| Methocarbamol Tablets, USP, 500 mgmethocarbamol | Methocarbamol 500 mg/1 | Tablet, Film coatedOral | Granulation Technology, Inc. | 63561-0173 |
| Methocarbamol Tablets, USP, 750 mgmethocarbamol | Methocarbamol 750 mg/1 | Tablet, Film coatedOral | Granulation Technology, Inc. | 63561-0174 |