Miacalcin
- Product NDC
- 72078-038
- 11-digit product format
- 720780038
- Labeler code
- 72078
- Product ID
- 72078-038_d54536c6-69ce-48d4-b2fc-6019cb9d09b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- calcitonin salmon
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- Mylan Institutional LLC
- Application
- NDA017808
- Marketing category
- NDA
- Marketing start
- 2022-06-16
- Substance
- CALCITONIN SALMON
- Active strength
- 200 [USP'U]/mL
- Pharmacologic classes
- Calcitonin [CS], Calcitonin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Miacalcin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CALCITONIN SALMON | 200 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7SFC6U2VI5 |
| Rxcui | 213570, 308866 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72078-038-02 | Miacalcin | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | | 4 |
| 72078-038-02 | Miacalcin | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72078-038 | MIACALCIN (CALCITONIN SALMON) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240913_753ecc6a-07be-4fc6-9032-cc6ad116a662.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72078-038-02 | 72078003802 | 1 VIAL, MULTI-DOSE in 1 CARTON (72078-038-02) / 2 mL in 1 VIAL, MULTI-DOSE | 2022-06-16 | 0000-00-00 | No | No | Current |