Milrinone Lactate
- Product NDC
- 42677-313
- 11-digit product format
- 426770313
- Labeler code
- 42677
- Product ID
- 42677-313_47b2ea09-87c3-2314-e063-6294a90a58b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Milrinone Lactate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Shandong New Time Pharmaceutical Co., Ltd.
- Application
- ANDA216373
- Marketing category
- ANDA
- Marketing start
- 2023-02-28
- Substance
- MILRINONE LACTATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Milrinone Lactate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MILRINONE LACTATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9K8XR81MO8 |
| Rxcui | 1791854, 1791859 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42677-313-01 | Milrinone Lactate | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 5 |
| 42677-313-10 | Milrinone Lactate | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42677-313 | MILRINONE LACTATE INJECTION, SOLUTION [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.] | 4 | Current NDC, 2 package rows | 20241127_0fdaee3c-2144-4ca7-9868-54d251f468c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42677-313-01 | 42677031301 | 10 mL in 1 VIAL | 10 ml | | | | Historical |
| 42677-313-10 | 42677031310 | 10 VIAL in 1 CARTON (42677-313-10) / 10 mL in 1 VIAL (42677-313-01) | 10 vial | 2023-03-01 | No | No | Historical |