Prescription drug · ANDA
Meclofenamate Sodium NDC 0378-2150
Meclofenamate sodium 50 mg/1 · Capsule · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-2150-01 | 00378215001 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2150-01)Marketed from Sep 3, 1986 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Meclofenamate Sodium
- Generic name (nonproprietary)
- meclofenamate sodium
- Active ingredients
- Meclofenamate sodium — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071081
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-2150_4be1c27e-b52c-472c-8795-16af910fa26eSPL ID 4be1c27e-b52c-472c-8795-16af910fa26eSPL set ID 96f19af4-de8f-4fd7-90d8-55fe6ebdd81dRxCUI 618552, 618557UNII 94NJ818U2WUPC 0303783000015, 0303782150018
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
N400378215001followed by a unit qualifier and the quantityPackage 00378-2150-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of meclofenamate sodium capsules and other treatment options before deciding to use meclofenamate sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Meclofenamate sodium capsules are indicated: • For reduction of fever in adults • For relief of mild to moderate pain in adults • For relief of signs and symptoms of juvenile arthritis. • For relief of the signs and symptoms of rheumatoid arthritis • For relief of the signs and symptoms of osteoarthritis. • For treatment of primary dysmenorrhea. • For acute or long-term use in the rel…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071081
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 |
|---|---|---|---|---|
| Meclofenamate Sodium | Meclofenamate sodium 100 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-3000 |