Prescription drug · ANDA
Methocarbamol NDC 68083-317
Methocarbamol 100 mg/mL · Injection · Intramuscular, Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-317-25 | 6808303172568083031725 | 25 VIAL in 1 CARTON (68083-317-25) / 10 mL in 1 VIAL (68083-317-01)Marketed from Nov 1, 2018 |
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
- Generic name (nonproprietary)
- methocarbamol
- Active ingredients
- Methocarbamol — 100 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211504
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 68083-317_36c2242f-82d7-4faa-a640-0a6e269038ffSPL ID 36c2242f-82d7-4faa-a640-0a6e269038ffSPL set ID 44c7fe99-8999-4747-9376-f13d3f9e5688RxCUI 238175UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N468083031725followed by a unit qualifier and the quantityPackage 68083-0317-25. 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 The injectable form of methocarbamol is 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 this drug 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.
About NDC 68083-317
- What is NDC 68083-317?
- 68083-317 is the product NDC for Methocarbamol, Methocarbamol 100 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methocarbamol.
- What is the active ingredient?
- Methocarbamol.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methocarbamol?
- 200 other product NDCs are listed under this name. See all Methocarbamol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methocarbamol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methocarbamolmethocarbamol tablets | Methocarbamol 500 mg/1 | Tablet, CoatedOral | American Health Packaging | 60687-945 | 60687-0945-01 |
| Methocarbamolmethocarbamol tablets | Methocarbamol 750 mg/1 | Tablet, CoatedOral | American Health Packaging | 60687-956 | 60687-0956-01 |
| Methocarbamol | Methocarbamol 500 mg/1 | TabletOral | REGIMED MEDICAL | 25685-240 | 25685-0240-10 |
| Methocarbamol | Methocarbamol 500 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-874 | 60760-0874-90 |
| Methocarbamolmethocarbamol tablets | Methocarbamol 750 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-0340 | 67046-0340-03 |
| Methocarbamol | Methocarbamol 500 mg/1 | TabletOral | Coupler LLC | 67046-1177 | 67046-1177-03 |
| Methocarbamol | Methocarbamol 500 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-722 | 82461-0722-90 |
| Methocarbamol | Methocarbamol 750 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-723 | 82461-0723-90 |
| Methocarbamolmethocarbamol tablets | Methocarbamol 500 mg/1 | Tablet, CoatedOral | Unit Dose Solutions, Inc. | 87441-086 | 87441-0086-01 |
| Methocarbamol | Methocarbamol 750 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-875 | 60760-0875-2860760-0875-4060760-0875-90 |
Other NDCs under ANDA 211504
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 | Methocarbamol 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-689 |
| Methocarbamol | Methocarbamol 100 mg/mL | InjectionIntramuscular, Intravenous | Dr.Reddys Laboratories Inc., | 43598-839 |
| Methocarbamol | Methocarbamol 100 mg/mL | Injection, SolutionIntramuscular, Intravenous | Meitheal Pharmaceuticals Inc. | 71288-716 |
| Methocarbamol | Methocarbamol 100 mg/mL | InjectionIntramuscular, Intravenous, Intravenous | JVET PHARMACEUTICALS LLC | 86211-114 |