Prescription drug · ANDA
Mefenamic acid NDC 42571-258
Mefenamic acid 250 mg/1 · Capsule · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-258-01 | 42571025801 | 100 CAPSULE in 1 BOTTLE (42571-258-01)Marketed from Nov 19, 2010 | |
| 42571-258-30 | 42571025830 | 30 CAPSULE in 1 BOTTLE (42571-258-30)Marketed from Nov 19, 2010 |
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)
- Mefenamic acid
- Generic name (nonproprietary)
- mefenamic acid
- Active ingredients
- Mefenamic acid — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Micro Labs LimitedNDC labeler code 42571
- 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 42571-258_482b411c-8d6f-8690-e063-6294a90af95fSPL ID 482b411c-8d6f-8690-e063-6294a90af95fSPL set ID 4b0788cd-bdca-4fa5-9eba-01a270613aabRxCUI 829500UNII 367589PJ2CUPC 0342571258306
- 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
N442571025801followed by a unit qualifier and the quantityPackage 42571-0258-01. 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)
Mefenamic acid capsules are a nonsteroidal anti-inflammatory drug indicated for: For management of mild to moderate pain in patient 14 years of age and older, when therapy will not exceed one week (7 days). ( 1.1 ) For treatment of primary dysmenorrhea. ( 1.2 ) 1.1 Mild to Moderate Pain Mefenamic acid capsules are indicated for management of mild to moderate pain in adults and pediatric patients 14 years of age and older, when therapy will not exceed one week (7 days). 1.2 Dysmenorrhea Mefenamic acid capsules are indicated for treatment of primary dysmenorrhea.
Excerpt only. Read the full label for complete information.
About NDC 42571-258
- What is NDC 42571-258?
- 42571-258 is the product NDC for Mefenamic acid, Mefenamic acid 250 mg/1 capsule, listed with the FDA by Micro Labs Limited. It has 2 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?
- Micro Labs Limited, NDC labeler code 42571. 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 | 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 | Bryant Ranch Prepack | 72162-2382 | 72162-2382-03 |
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 | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0306 |
| Mefenamic acid | Mefenamic acid 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2382 |