Prescription drug · ANDA
Ketoprofen NDC 0276-0504
Ketoprofen 25 mg/1 · Capsule · Oral · Misemer Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0276-0504-10 | 0027605041000276050410 | 100 CAPSULE in 1 BOTTLE (0276-0504-10)Marketed from Nov 1, 2021 |
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)
- Ketoprofen
- Generic name (nonproprietary)
- ketoprofen
- Active ingredients
- Ketoprofen — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Misemer Pharmaceuticals, Inc.NDC labeler code 0276
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074014
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 0276-0504_4add4a71-ad1b-2577-e063-6294a90a3263SPL ID 4add4a71-ad1b-2577-e063-6294a90a3263SPL set ID d0f47ab6-29ff-df07-e053-2a95a90a2b51RxCUI 197854, 197855, 197856UNII 90Y4QC304KUPC 0302760504102, 0302760507103
- 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
N400276050410followed by a unit qualifier and the quantityPackage 00276-0504-10. 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 ketoprofen capsules USP and other treatment options before deciding to use ketoprofen capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Ketoprofen capsules USP are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen capsules USP are indicated for the management of pain. Ketoprofen capsules USP are also indicated for treatment of primary dysmenorrhea.
Excerpt only. Read the full label for complete information.
About NDC 0276-0504
- What is NDC 0276-0504?
- 0276-0504 is the product NDC for Ketoprofen, Ketoprofen 25 mg/1 capsule, listed with the FDA by Misemer Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ketoprofen.
- What is the active ingredient?
- Ketoprofen.
- Who is the labeler?
- Misemer Pharmaceuticals, Inc., NDC labeler code 0276. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ketoprofen?
- 5 other product NDCs are listed under this name. See all Ketoprofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ketoprofen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ketoprofen | Ketoprofen 75 mg/1 | CapsuleOral | Marnel Pharmaceuticals, Inc. | 0682-0150 | 00682-0150-60 |
| Ketoprofen | Ketoprofen 50 mg/1 | CapsuleOral | Oncora Pharma, LLC | 85477-111 | 85477-0111-01 |
| Ketoprofen | Ketoprofen 75 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0507 | 00276-0507-10 |
| Ketoprofen | Ketoprofen 50 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0506 | 00276-0506-10 |
| Ketoprofen | Ketoprofen 200 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-8200 | 00378-8200-01 |
Other NDCs under ANDA 074014
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 |
|---|---|---|---|---|
| Ketoprofen | Ketoprofen 50 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0506 |
| Ketoprofen | Ketoprofen 75 mg/1 | CapsuleOral | Misemer Pharmaceuticals, Inc. | 0276-0507 |
| Ketoprofen | Ketoprofen 75 mg/1 | CapsuleOral | Marnel Pharmaceuticals, Inc. | 0682-0150 |
| Ketoprofen | Ketoprofen 50 mg/1 | CapsuleOral | Oncora Pharma, LLC | 85477-111 |
| Orudisketoprofen | Ketoprofen 75 mg/1 | CapsuleOral | Allegis Pharmaceuticals, Inc. | 28595-031 |