Prescription drug · ANDA
Doxercalciferol NDC 62135-452
Doxercalciferol 2.5 ug/1 · Capsule · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-452-30 | 6213504523062135045230 | 30 CAPSULE in 1 BOTTLE (62135-452-30)Marketed from Jan 26, 2023 |
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)
- Doxercalciferol
- Generic name (nonproprietary)
- doxercalciferol
- Active ingredients
- Doxercalciferol — 2.5 ug/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205360
- Marketing start
- Listing expires
- Other FDA classes
- Ergocalciferols (Chemical structure)
- Identifiers
- Product ID 62135-452_241fa54b-26c7-a31f-e063-6394a90a7a78SPL ID 241fa54b-26c7-a31f-e063-6394a90a7a78SPL set ID 356fb38a-791c-48f0-9312-6203ae57d80cRxCUI 310023, 406503, 858262UNII 3DIZ9LF5Y9UPC 0362135451301, 0362135452308, 0362135450304
- Pharmacologic class
- Vitamin D2 Analog
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
N462135045230followed by a unit qualifier and the quantityPackage 62135-0452-30. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis. Doxercalciferol Capsules is a synthetic vitamin D2 analog: Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 62135-452
- What is NDC 62135-452?
- 62135-452 is the product NDC for Doxercalciferol, Doxercalciferol 2.5 ug/1 capsule, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxercalciferol.
- What is the active ingredient?
- Doxercalciferol.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Doxercalciferol?
- 14 other product NDCs are listed under this name. See all Doxercalciferol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxercalciferol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Doxercalciferol | Doxercalciferol .5 ug/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4642 | 70518-4642-0070518-4642-02 |
| Doxercalciferol | Doxercalciferol 4 ug/2mL | Injection, SolutionIntravenous | Alembic Pharmaceuticals Inc. | 62332-690 | 62332-0690-3062332-0690-50 |
| Doxercalciferol | Doxercalciferol 2 ug/mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-357 | 55150-0357-50 |
| Doxercalciferol | Doxercalciferol 4 ug/2mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-358 | 55150-0358-50 |
| Doxercalciferol | Doxercalciferol 4 ug/2mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-359 | 55150-0359-50 |
| Doxercalciferol | Doxercalciferol .5 ug/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-538 | 23155-0538-25 |
| Doxercalciferol | Doxercalciferol 1 ug/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-539 | 23155-0539-25 |
| Doxercalciferol | Doxercalciferol 2.5 ug/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-540 | 23155-0540-25 |
| Doxercalciferol | Doxercalciferol .5 ug/1 | CapsuleOral | Chartwell RX, LLC | 62135-450 | 62135-0450-30 |
| Doxercalciferol | Doxercalciferol 1 ug/1 | CapsuleOral | Chartwell RX, LLC | 62135-451 | 62135-0451-30 |
Other NDCs under ANDA 205360
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 |
|---|---|---|---|---|
| Doxercalciferol | Doxercalciferol .5 ug/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-538 |
| Doxercalciferol | Doxercalciferol 1 ug/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-539 |
| Doxercalciferol | Doxercalciferol 2.5 ug/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-540 |
| Doxercalciferol | Doxercalciferol .5 ug/1 | CapsuleOral | Chartwell RX, LLC | 62135-450 |
| Doxercalciferol | Doxercalciferol 1 ug/1 | CapsuleOral | Chartwell RX, LLC | 62135-451 |
| Doxercalciferol | Doxercalciferol .5 ug/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4642 |