Prescription drug · ANDA
Folic Acid NDC 53746-361
Folic acid 1 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-361-01 | 53746036101 | 100 TABLET in 1 BOTTLE (53746-361-01)Marketed from Mar 7, 2022 | |
| 53746-361-10 | 53746036110 | 1000 TABLET in 1 BOTTLE (53746-361-10)Marketed from Mar 7, 2022 |
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)
- Folic Acid
- Generic name (nonproprietary)
- folic acid
- Active ingredients
- Folic acid — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040625
- Marketing start
- Listing expires
- Identifiers
- Product ID 53746-361_299a16c1-9627-45e2-a30c-e0f07ae9399aSPL ID 299a16c1-9627-45e2-a30c-e0f07ae9399aSPL set ID fd85395e-6a0b-4072-a80b-36095c0c6dd6RxCUI 310410UNII 935E97BOY8UPC 0353746361011
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
N453746036101followed by a unit qualifier and the quantityPackage 53746-0361-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040625
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 |
|---|---|---|---|---|
| Folic Acid | Folic acid 1 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-361 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-004 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4306 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | American Health Packaging | 60687-681 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7224 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-235 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2137 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3513 |