Phenylephrine Hydrochloride
- Product NDC
- 70069-591
- 11-digit product format
- 700690591
- Labeler code
- 70069
- Product ID
- 70069-591_5bc23817-cddb-4448-bbf3-969db4cee912
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA215617
- Marketing category
- ANDA
- Marketing start
- 2025-03-04
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- .1 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 | .1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04JA59TNSJ |
| Rxcui | 2262018 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-591-01 | Phenylephrine Hydrochloride | 5 mL in 1 AMPULE | SOLUTION | 5 | | 7 |
| 70069-591-10 | Phenylephrine Hydrochloride | 10 in 1 CARTON | SOLUTION | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-591 | PHENYLEPHRINE HYDROCHLORIDE SOLUTION [SOMERSET THERAPEUTICS, LLC] | 7 | Current NDC, 2 package rows | 20250306_170e63f1-23f4-4839-ab89-b81832d94a56.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 |
|---|
| 70069-591-01 | 70069059101 | 5 mL in 1 AMPULE | 5 ml | | | | Historical |
| 70069-591-10 | 70069059110 | 10 AMPULE in 1 CARTON (70069-591-10) / 5 mL in 1 AMPULE (70069-591-01) | 10 ampule | 2025-03-04 | No | No | Current |