DOBUTAMINE
- Product NDC
- 51662-1337
- 11-digit product format
- 516621337
- Labeler code
- 51662
- Product ID
- 51662-1337_11c1b110-433c-7887-e063-6294a90a1e52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOBUTAMINE
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA074086
- Marketing category
- ANDA
- Marketing start
- 2018-11-26
- Substance
- DOBUTAMINE HYDROCHLORIDE
- Active strength
- 12.5 mg/mL
- Pharmacologic classes
- Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DOBUTAMINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOBUTAMINE HYDROCHLORIDE | 12.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0WR771DJXV |
| Rxcui | 1812168 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1337-1 | DOBUTAMINE | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 20 | | 6 |
| 51662-1337-2 | DOBUTAMINE | 1 in 1 POUCH | INJECTION, SOLUTION, CONCENTRATE | 1 | | 6 |
| 51662-1337-2 | DOBUTAMINE | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 20 | | 6 |
| 51662-1337-3 | DOBUTAMINE | 10 in 1 CASE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1337 | DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240220_7b9ea626-7072-2e77-e053-2a91aa0a9215.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1337-1 | 51662133701 | 20 mL in 1 VIAL, SINGLE-DOSE (51662-1337-1) | 20 ml | 2018-11-26 | 0000-00-00 | No | No | Current |
| 51662-1337-2 | 51662133702 | 1 in 1 POUCH | | | | | | Historical |
| 51662-1337-3 | 51662133703 | 10 POUCH in 1 CASE (51662-1337-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1337-2) / 20 mL in 1 VIAL, SINGLE-DOSE | 10 pouch | 2022-06-12 | 0000-00-00 | No | No | Current |