Prescription drug · ANDA
Ergocalciferol Capsules, NDC 53401-021
Ergocalciferol 1.25 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53401-021-08 | 5340100210853401002108 | 8 CAPSULE in 1 BOTTLE (53401-021-08)Marketed from Jul 8, 2026 | |
| 53401-021-12 | 5340100211253401002112 | 12 CAPSULE in 1 BOTTLE (53401-021-12)Marketed from Jul 8, 2026 | |
| 53401-021-13 | 5340100211353401002113 | 13 CAPSULE in 1 BOTTLE (53401-021-13)Marketed from Jul 8, 2026 |
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)
- Ergocalciferol Capsules,
- Generic name (nonproprietary)
- ergocalciferol capsules,
- Active ingredients
- Ergocalciferol — 1.25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204276
- Marketing start
- Listing expires
- Other FDA classes
- Ergocalciferols (Chemical structure)
- Identifiers
- Product ID 53401-021_564537cc-0d46-3656-e063-6294a90ace99SPL ID 564537cc-0d46-3656-e063-6294a90ace99SPL set ID 56454180-0ae8-a267-e063-6394a90a491cRxCUI 1367410UNII VS041H42XC
- Pharmacologic class
- Provitamin D2 Compound
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
N453401002108followed by a unit qualifier and the quantityPackage 53401-0021-08. 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 Ergocalciferol Capsules are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
Excerpt only. Read the full label for complete information.
About NDC 53401-021
- What is NDC 53401-021?
- 53401-021 is the product NDC for Ergocalciferol Capsules,, Ergocalciferol 1.25 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ergocalciferol Capsules,.
- What is the active ingredient?
- Ergocalciferol.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ergocalciferol Capsules,?
- 6 other product NDCs are listed under this name. See all Ergocalciferol Capsules, NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ergocalciferol Capsules, products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4042 | 68788-4042-0168788-4042-0268788-4042-03+1 more |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3472 | 70518-3472-01 |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-730 | 51655-0730-80 |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Epic Pharma LLC | 42806-547 | 42806-0547-0142806-0547-05 |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Proficient Rx LP | 71205-676 | 71205-0676-0471205-0676-0871205-0676-12+1 more |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2003 | 71335-2003-0171335-2003-02 |
Other NDCs under ANDA 204276
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 |
|---|---|---|---|---|
| Ergocalciferolergocalciferol capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1691 |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2003 |
| Ergocalciferol | Ergocalciferol 1.25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2295 |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4042 |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Proficient Rx LP | 71205-676 |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3472 |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-730 |
| Ergocalciferol Capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Epic Pharma LLC | 42806-547 |
| Ergocalciferolergocalciferol capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5844 |
| Ergocalciferolergocalciferol capsules, | Ergocalciferol 1.25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7913 |
| Ergocalciferol (Vitamin D2) | Ergocalciferol 1.25 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0130 |