Prescription drug · ANDA
Fenofibric Acid NDC 62332-245
Fenofibric acid 135 mg/1 · Capsule, Delayed release · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-245-30 | 6233202453062332024530 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-245-30)Marketed from May 15, 2017 | |
| 62332-245-90 | 6233202459062332024590 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-245-90)Marketed from May 15, 2017 | |
| 62332-245-91 | 6233202459162332024591 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-245-91)Marketed from May 15, 2017 |
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)
- Fenofibric Acid
- Generic name (nonproprietary)
- fenofibric acid
- Active ingredients
- Fenofibric acid — 135 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208705
- Marketing start
- Listing expires
- Identifiers
- Product ID 62332-245_be2cddd4-5895-4bac-b345-4104987661a0SPL ID be2cddd4-5895-4bac-b345-4104987661a0
- Pharmacologic class
- Peroxisome Proliferator Receptor alpha Agonist
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
N462332024530followed by a unit qualifier and the quantityPackage 62332-0245-30. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 62332-245
- What is NDC 62332-245?
- 62332-245 is the product NDC for Fenofibric Acid, Fenofibric acid 135 mg/1 capsule, delayed release, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fenofibric Acid.
- What is the active ingredient?
- Fenofibric acid.
- Who is the labeler?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fenofibric Acid?
- 13 other product NDCs are listed under this name. See all Fenofibric Acid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fenofibric 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) |
|---|---|---|---|---|---|
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1324 | 00115-1324-10 |
| Fenofibric Acid | Fenofibric acid 135 mg/1 | Capsule, Delayed releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1325 | 00115-1325-10 |
| Fenofibric acid | Choline fenofibrate 45 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-294 | 33342-0294-1033342-0294-12 |
| Fenofibric acid | Choline fenofibrate 135 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-295 | 33342-0295-1033342-0295-56 |
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Aurobindo Pharma Limited | 59651-216 | 59651-0216-90 |
| Fenofibric Acid | Fenofibric acid 135 mg/1 | Capsule, Delayed releaseOral | Aurobindo Pharma Limited | 59651-217 | 59651-0217-90 |
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Leading Pharma, LLC | 69315-281 | 69315-0281-09 |
| Fenofibric Acid | Fenofibric acid 135 mg/1 | Capsule, Delayed releaseOral | Leading Pharma, LLC | 69315-282 | 69315-0282-09 |
| Fenofibric Acid | Fenofibric acid 135 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-245 | 46708-0245-3046708-0245-9046708-0245-91 |
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-244 | 46708-0244-3046708-0244-9046708-0244-91 |
Other NDCs under ANDA 208705
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 |
|---|---|---|---|---|
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-244 |
| Fenofibric Acid | Fenofibric acid 135 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-245 |
| Fenofibric Acid | Fenofibric acid 45 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-244 |