Prescription drug · ANDA
Teriparatide NDC 0548-2311
Teriparatide 250 ug/mL · Injection · Subcutaneous · Amphastar Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0548-2311-00 | 00548231100 | 1 SYRINGE in 1 CARTON (0548-2311-00) / 2.24 mL in 1 SYRINGEMarketed from Dec 22, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Teriparatide
- Generic name (nonproprietary)
- teriparatide
- Active ingredients
- Teriparatide — 250 ug/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213641
- Marketing start
- Listing expires
- Other FDA classes
- Parathyroid Hormone (Chemical structure)
- Identifiers
- Product ID 0548-2311_0fe663ce-2f30-4de1-b873-804b21779241SPL ID 0fe663ce-2f30-4de1-b873-804b21779241SPL set ID d38b470a-2e62-487b-b3e7-134d3d1958b5RxCUI 1435115UNII 10T9CSU89I
- Pharmacologic class
- Parathyroid Hormone 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
N400548231100followed by a unit qualifier and the quantityPackage 00548-2311-00. 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)
Teriparatide injection is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide injection reduces the risk of vertebral and nonvertebral fractures. To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213641
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 |
|---|---|---|---|---|
| Teriparatide | Teriparatide 250 ug/mL | InjectionSubcutaneous | BluePoint Laboratories | 68001-693 |