Phenylephrine Hydrochloride
- Product NDC
- 63323-751
- 11-digit product format
- 633230751
- Labeler code
- 63323
- Product ID
- 63323-751_34ab57b5-98e6-4284-8f0a-96334a07a915
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA210665
- Marketing category
- ANDA
- Marketing start
- 2019-05-25
- 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 | 1666372 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-751-00 | Phenylephrine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 8 |
| 63323-751-01 | Phenylephrine Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 8 |
| 63323-751-05 | Phenylephrine Hydrochloride | 5 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 5 | | 4 |
| 63323-751-05 | Phenylephrine Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 4 |
| 63323-751-10 | Phenylephrine Hydrochloride | 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 10 | | 4 |
| 63323-751-10 | Phenylephrine Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 4 |
| 63323-751-03 | Phenylephrine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 2 |
| 63323-751-13 | Phenylephrine Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-751 | PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC
] | 7 | Current NDC, Legacy NDC, 2 package rows | 20231208_1e77b9c8-fa17-4aa4-adc8-ff716ab2e5d7.zip |
| 63323-751 | PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC
] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240125_c7026b15-1228-4acb-beed-4474fcdbb972.zip |
| 63323-751 | PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC
] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240110_f2dce7f1-6538-4747-9792-665eee45c0a9.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 |
|---|
| 63323-751-00 | 63323075100 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 63323-751-01 | 63323075101 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-751-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-751-00) | | 2019-05-25 | 0000-00-00 | No | No | Current |
| 63323-751-03 | 63323075103 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 63323-751-05 | 63323075105 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-751-05) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE | | 2019-05-25 | 0000-00-00 | No | No | Current |
| 63323-751-10 | 63323075110 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-751-10) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | | 2019-05-25 | 0000-00-00 | No | No | Current |
| 63323-751-13 | 63323075113 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-751-13) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-751-03) | | 2019-05-25 | 0000-00-00 | No | No | Current |