PHENYLEPHRINE HYDROCHLORIDE
- Product NDC
- 70069-811
- 11-digit product format
- 700690811
- Labeler code
- 70069
- Product ID
- 70069-811_18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA213318
- Marketing category
- ANDA
- Marketing start
- 2023-07-17
- 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 |
|---|
| 70069-811-01 | PHENYLEPHRINE HYDROCHLORIDE | 1 mL in 1 VIAL | INJECTION | 1 | | 1 |
| 70069-811-25 | PHENYLEPHRINE HYDROCHLORIDE | 25 in 1 CARTON | INJECTION | 25 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-811 | PHENYLEPHRINE HYDROCHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC] | 1 | Current NDC, 2 package rows | 20230718_18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70069-811-01 | 70069081101 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 70069-811-25 | 70069081125 | 25 VIAL in 1 CARTON (70069-811-25) / 1 mL in 1 VIAL (70069-811-01) | 25 vial | 2023-07-17 | No | No | Historical |