Phenylephrine Hydrochloride
- Product NDC
- 70594-065
- 11-digit product format
- 705940065
- Labeler code
- 70594
- Product ID
- 70594-065_69ee5794-96b0-4975-aadd-d8dbcc73ca3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Xellia Pharmaceuticals USA LLC
- Application
- ANDA213318
- Marketing category
- ANDA
- Marketing start
- 2022-01-01
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 100 mg/10mL
- 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 | 100 mg/10mL |
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 |
|---|
| 70594-065-01 | Phenylephrine Hydrochloride | 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 10 | | 1 |
| 70594-065-01 | Phenylephrine Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 70594-065-02 | Phenylephrine Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | | 1 |
| 70594-065-02 | Phenylephrine Hydrochloride | 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70594-065 | PHENYLEPHRINE HYDROCHLORIDE INJECTION [XELLIA PHARMACEUTICALS USA LLC] | 1 | Current NDC, Legacy NDC, 4 package rows | 20220302_abd39d9c-fcda-4d01-8a58-1d54ba7ac651.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 |
|---|
| 70594-065-01 | 70594006501 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-065-01) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2022-01-01 | 0000-00-00 | No | No | Current |
| 70594-065-02 | 70594006502 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-065-02) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2022-01-01 | 0000-00-00 | No | No | Current |