PHENYLEPHRINE HYDROCHLORIDE
- Product NDC
- 68083-680
- 11-digit product format
- 680830680
- Labeler code
- 68083
- Product ID
- 68083-680_b31e3905-8ee4-46db-ba72-358ea7d44f10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA218129
- Marketing category
- ANDA
- Marketing start
- 2025-09-17
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 25 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 | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04JA59TNSJ |
| Rxcui | 1234571, 1234579 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-680-01 | PHENYLEPHRINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
| 68083-680-01 | PHENYLEPHRINE HYDROCHLORIDE | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-680-01 | 68083068001 | 1 BOTTLE, DROPPER in 1 CARTON (68083-680-01) / 15 mL in 1 BOTTLE, DROPPER | 2025-09-17 | No | No | Current |