Phenylephrine Hydrochloride
- Product NDC
- 0781-3422
- 11-digit product format
- 007813422
- Labeler code
- 0781
- Product ID
- 0781-3422_14eec16d-4652-44a3-8cd3-a37b4280deb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sandoz Inc
- Application
- ANDA208905
- Marketing category
- ANDA
- Marketing start
- 2019-09-05
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 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
- Phenylephrine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04JA59TNSJ |
| Rxcui | 1232651, 1666372 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-3422-70 | Phenylephrine Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 20 |
| 0781-3422-70 | Phenylephrine Hydrochloride | 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 10 | | 20 |
| 0781-3422-71 | Phenylephrine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 20 |
| 0781-3422-75 | Phenylephrine Hydrochloride | 5 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 5 | | 20 |
| 0781-3422-92 | Phenylephrine Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | | 20 |
| 0781-3422-95 | Phenylephrine Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-3422 | PHENYLEPHRINE HYDROCHLORIDE INJECTION [SANDOZ INC] | 19 | Current NDC, Legacy NDC, 6 package rows | 20221018_6feb2da2-05ef-47bb-9d8d-01b81ad69059.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 |
|---|
| 0781-3422-70 | 00781342270 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3422-70) > 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | | 2019-09-05 | 2021-04-30 | No | No | Current |
| 0781-3422-71 | 00781342271 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 0781-3422-75 | 00781342275 | 5 mL in 1 VIAL, PHARMACY BULK PACKAGE | 5 ml | | | | | Historical |
| 0781-3422-92 | 00781342292 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3422-92) / 1 mL in 1 VIAL, SINGLE-DOSE (0781-3422-71) | | 2019-12-16 | 0000-00-00 | No | No | Current |
| 0781-3422-95 | 00781342295 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3422-95) > 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0781-3422-75) | | 2019-09-05 | 2021-04-30 | No | No | Current |