Prescription drug · ANDA
Doxercalciferol NDC 68083-300
Doxercalciferol 4 ug/2mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-300-50 | 6808303005068083030050 | 50 VIAL, SINGLE-DOSE in 1 CARTON (68083-300-50) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-300-01)Marketed from Sep 26, 2019 |
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 — 4 ug/2mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210452
- Marketing start
- Listing expires
- Other FDA classes
- Ergocalciferols (Chemical structure)
- Identifiers
- Product ID 68083-300_db27a30b-8264-4248-b83e-b6ba0feafbf0SPL ID db27a30b-8264-4248-b83e-b6ba0feafbf0SPL set ID f0d79a1b-c7fb-4521-941a-5d6c2fd50170RxCUI 282609, 1790219UNII 3DIZ9LF5Y9
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N468083030050followed by a unit qualifier and the quantityPackage 68083-0300-50. 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 Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. Doxercalciferol is a synthetic vitamin D 2 analog: • Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.
Excerpt only. Read the full label for complete information.
About NDC 68083-300
- What is NDC 68083-300?
- 68083-300 is the product NDC for Doxercalciferol, Doxercalciferol 4 ug/2mL injection, solution, listed with the FDA by Gland Pharma Limited. 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 210452
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 4 ug/2mL | InjectionIntravenous | Dr.Reddy's Laboratories Inc | 43598-850 |
| Doxercalciferol | Doxercalciferol 4 ug/2mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-359 |