Phenylephrine hydrochloride
- Product NDC
- 81284-211
- 11-digit product format
- 812840211
- Labeler code
- 81284
- Product ID
- 81284-211_9302b62e-3f80-4e5c-afa5-a775ed2c2ebe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Provepharm Inc.
- Application
- ANDA211081
- Marketing category
- ANDA
- Marketing start
- 2020-08-12
- 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 |
|---|
| 81284-211-00 | Phenylephrine hydrochloride | 1 mL in 1 VIAL | INJECTION | 1 | | 6 |
| 81284-211-25 | Phenylephrine hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81284-211 | PHENYLEPHRINE HYDROCHLORIDE INJECTION [PROVEPHARM INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241103_e1d3881f-fa9e-4d68-8ef0-9e03435fc292.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 |
|---|
| 81284-211-00 | 81284021100 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 81284-211-25 | 81284021125 | 25 VIAL in 1 CARTON (81284-211-25) / 1 mL in 1 VIAL (81284-211-00) | 25 vial | 2020-08-12 | 0000-00-00 | No | No | Current |