Phenylephrine Hydrochloride
- Product NDC
- 65219-388
- 11-digit product format
- 652190388
- Labeler code
- 65219
- Product ID
- 65219-388_b54a0c59-e5e4-4fd7-ba91-c991ce87b148
- 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
- 2026-05-10
- 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 |
|---|
| 65219-388-00 | Phenylephrine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 1 |
| 65219-388-01 | Phenylephrine Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-388-00 | 65219038800 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |
| 65219-388-01 | 65219038801 | 25 VIAL, SINGLE-DOSE in 1 CARTON (65219-388-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-388-00) | | 2026-05-10 | No | No | Current |