Prescription drug · ANDA
Mefenamic Acid NDC 80425-0423
Mefenamic acid 250 mg/1 · Capsule · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0423-1 | 80425042301 | 30 CAPSULE in 1 BOTTLE (80425-0423-1)Marketed from Jul 19, 2024 | |
| 80425-0423-2 | 80425042302 | 60 CAPSULE in 1 BOTTLE (80425-0423-2)Marketed from Jul 19, 2024 | |
| 80425-0423-3 | 80425042303 | 90 CAPSULE in 1 BOTTLE (80425-0423-3)Marketed from Jul 19, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Mefenamic Acid
- Generic name (nonproprietary)
- mefenamic acid
- Active ingredients
- Mefenamic acid — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091322
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0423_1e927779-411b-b5f5-e063-6394a90aae93SPL ID 1e927779-411b-b5f5-e063-6394a90aae93SPL set ID 1e927779-411a-b5f5-e063-6394a90aae93RxCUI 829500UNII 367589PJ2C
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N480425042301followed by a unit qualifier and the quantityPackage 80425-0423-01. 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 mefenamic acid capsules and other treatment options before deciding to use mefenamic acid capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ; Gastrointestinal Bleeding, Ulceration, and Perforation ). Mefenamic acid capsules are indicated: For relief of mild to moderate pain in patients ≥14 years of age, when therapy will not exceed one week (7 days). For treatment of primary dysmenorrhea.
Excerpt only. Read the full label for complete information.
About NDC 80425-0423
- What is NDC 80425-0423?
- 80425-0423 is the product NDC for Mefenamic Acid, Mefenamic acid 250 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mefenamic Acid.
- What is the active ingredient?
- Mefenamic acid.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mefenamic Acid?
- 5 other product NDCs are listed under this name. See all Mefenamic Acid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mefenamic Acid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mefenamic Acid | Mefenamic acid 250 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0306 | 80425-0306-0180425-0306-0280425-0306-03 |
| Mefenamic Acid | Mefenamic acid 250 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc | 0276-0509 | 00276-0509-30 |
| Mefenamic Acid | Mefenamic acid 250 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-185 | 68180-0185-06 |
| Mefenamic acid | Mefenamic acid 250 mg/1 | CapsuleOral | Micro Labs Limited | 42571-258 | 42571-0258-0142571-0258-30 |
| Mefenamic acid | Mefenamic acid 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2382 | 72162-2382-03 |
Other NDCs under ANDA 091322
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 |
|---|---|---|---|---|
| Mefenamic Acid | Mefenamic acid 250 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-185 |