Phenylephrine Hydrochloride
- Product NDC
- 0641-6189
- 11-digit product format
- 006416189
- Labeler code
- 0641
- Product ID
- 0641-6189_f73e455e-cbfa-48af-b4ce-505de8e8f761
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA203826
- Marketing category
- NDA
- Marketing start
- 2019-06-19
- 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 |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 04JA59TNSJ |
| Rxcui | 1232651, 1666372, 2262018, 2634228, 2634233, 2634235 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-6189-01 | Phenylephrine Hydrochloride | 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 10 | 12 | |
| 0641-6189-10 | Phenylephrine Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0641-6189 | PHENYLEPHRINE HYDROCHLORIDE INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTABLE, LIPOSOMAL [HIKMA PHARMACEUTICALS USA INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240410_e1a7ab4b-0afe-4463-a039-5be0323cf2f7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634233 | IMMPHENTIV 1000 MCG in 10 ML Injection | PSN | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634235 | IMMPHENTIV 500 MCG in 5 ML Injection | PSN | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 1666372 | phenylephrine HCl 10 MG in 1 ML Injection | PSN | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 1232651 | phenylephrine HCl 10 MG/ML Injectable Solution | PSN | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634228 | phenylephrine hydrochloride 1000 MCG in 10 ML Injection | PSN | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2262018 | phenylephrine hydrochloride 500 MCG in 5 mL Injection | PSN | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634233 | 10 ML phenylephrine hydrochloride 0.1 MG/ML Injection [Immphentiv] | SBD | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634235 | 5 ML phenylephrine hydrochloride 0.1 MG/ML Injection [Immphentiv] | SBD | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 1666372 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection | SCD | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634228 | 10 ML phenylephrine hydrochloride 0.1 MG/ML Injection | SCD | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2262018 | 5 ML phenylephrine hydrochloride 0.1 MG/ML Injection | SCD | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 1232651 | phenylephrine hydrochloride 10 MG/ML Injectable Solution | SCD | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634233 | Immphentiv 0.1 MG/ML per 10 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634235 | Immphentiv 0.1 MG/ML per 5 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634235 | Immphentiv 0.5 MG per 5 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634233 | Immphentiv 1 MG per 10 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634233 | Immphentiv 1000 MCG per 10 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634235 | Immphentiv 500 MCG per 5 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 1666372 | phenylephrine HCl 10 MG per 1 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634228 | phenylephrine hydrochloride 0.1 MG/ML per 10 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 1232651 | phenylephrine hydrochloride 1 % Injectable Solution | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634228 | phenylephrine hydrochloride 1 MG per 10 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 1232651 | phenylephrine hydrochloride 100 MG per 10 ML Injectable Solution | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2634228 | phenylephrine hydrochloride 1000 MCG per 10 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 1232651 | phenylephrine hydrochloride 50 MG per 5 ML Injectable Solution | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
| 2262018 | phenylephrine hydrochloride 500 MCG per 5 ML Injection | SY | e1a7ab4b-0afe-4463-a039-5be0323cf2f7 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0641-6189-01 | 00641618901 | 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | 10 ml | Historical | ||||
| 0641-6189-10 | 00641618910 | 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0641-6189-10) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6189-01) | 2019-06-19 | 0000-00-00 | No | No | Current |