Teriparatide
- Product NDC
- 0548-2311
- 11-digit product format
- 005482311
- Labeler code
- 0548
- Product ID
- 0548-2311_0fe663ce-2f30-4de1-b873-804b21779241
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Teriparatide
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Amphastar Pharmaceuticals, Inc.
- Application
- ANDA213641
- Marketing category
- ANDA
- Marketing start
- 2025-12-22
- Substance
- TERIPARATIDE
- Active strength
- 250 ug/mL
- Pharmacologic classes
- Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Teriparatide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERIPARATIDE | 250 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 10T9CSU89I |
| Rxcui | 1435115 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0548-2311-00 | Teriparatide | 2.24 mL in 1 SYRINGE | INJECTION | 2.24 | | 2 |
| 0548-2311-00 | Teriparatide | 1 in 1 CARTON | INJECTION | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0548-2311-00 | 00548231100 | 1 SYRINGE in 1 CARTON (0548-2311-00) / 2.24 mL in 1 SYRINGE | 1 syringe | 2025-12-22 | No | No | Historical |