Prescription drug · ANDA
Folic Acid NDC 11534-165
Folic acid 1 mg/1 · Tablet · Oral · SUNRISE PHARMACEUTICAL, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11534-165-01 | 11534016501 | 100 TABLET in 1 BOTTLE (11534-165-01)Marketed from Aug 4, 2015 | |
| 11534-165-03 | 11534016503 | 1000 TABLET in 1 BOTTLE (11534-165-03)Marketed from Aug 4, 2015 | |
| 11534-165-90 | 11534016590 | 90 TABLET in 1 BOTTLE (11534-165-90)Marketed from Sep 29, 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)
- Folic Acid
- Generic name (nonproprietary)
- folic acid
- Active ingredients
- Folic acid — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SUNRISE PHARMACEUTICAL, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204418
- Marketing start
- Listing expires
- Identifiers
- Product ID 11534-165_5250e701-9f7a-42a8-bae9-95c4779f06aaSPL ID 5250e701-9f7a-42a8-bae9-95c4779f06aaSPL set ID 6854412b-7ecb-4107-85eb-730f14e23f06RxCUI 310410UNII 935E97BOY8
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
N411534016501followed by a unit qualifier and the quantityPackage 11534-0165-01. 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, USP is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, USP (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 204418
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 | A-S Medication Solutions | 50090-3119 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-6760 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-791 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | DIRECT RX | 72189-199 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2557 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | Coupler LLC | 67046-0719 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0613 |
| Folic Acid | Folic acid 1 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-656 |