Prescription drug · ANDA
Mefenamic Acid NDC 80425-0306
Mefenamic acid 250 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0306-1 | 80425030601 | 30 CAPSULE in 1 BOTTLE (80425-0306-1)Marketed from Apr 6, 2023 | |
| 80425-0306-2 | 80425030602 | 60 CAPSULE in 1 BOTTLE (80425-0306-2)Marketed from Apr 6, 2023 | |
| 80425-0306-3 | 80425030603 | 90 CAPSULE in 1 BOTTLE (80425-0306-3)Marketed from Apr 6, 2023 |
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 Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090562
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0306_2a9ba8f4-6cef-e827-e063-6394a90a0300SPL ID 2a9ba8f4-6cef-e827-e063-6394a90a0300SPL set ID f8b1a4a2-83fc-6b4b-e053-6394a90ac46aRxCUI 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
N480425030601followed by a unit qualifier and the quantityPackage 80425-0306-01. 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)
Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). Mefenamic acid is 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 80425-0306
- What is NDC 80425-0306?
- 80425-0306 is the product NDC for Mefenamic Acid, Mefenamic acid 250 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy 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 Pharmacy 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 of Tennessee, LLC | 80425-0423 | 80425-0423-0180425-0423-0280425-0423-03 |
| 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 | Bryant Ranch Prepack | 72162-2382 | 72162-2382-03 |
| Mefenamic acid | Mefenamic acid 250 mg/1 | CapsuleOral | Micro Labs Limited | 42571-258 | 42571-0258-0142571-0258-30 |
Other NDCs under ANDA 090562
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 | Micro Labs Limited | 42571-258 |
| Mefenamic acid | Mefenamic acid 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2382 |