Phenylephrine Hydrochloride
- Product NDC
- 58657-853
- 11-digit product format
- 586570853
- Labeler code
- 58657
- Product ID
- 58657-853_4bab5061-fc5e-bd93-e063-6294a90abb9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Method Pharmaceuticals, LLC
- Application
- ANDA218412
- Marketing category
- ANDA
- Marketing start
- 2026-02-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phenylephrine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 04JA59TNSJ |
| Rxcui | 1232651, 1666372 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58657-853-01 | Phenylephrine Hydrochloride | 10 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58657-853-01 | ML - Milliliter | 58657-853 | 0b106889-5d59-4e29-9f0f-e85d7fa3a7f3 | 1 | 2026-05-22 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1666372 | phenylephrine HCl 10 MG in 1 ML Injection | PSN | 4bab505d-d5c8-8c3b-e063-6394a90ad18a | 1 |
| 1232651 | phenylephrine HCl 10 MG/ML Injectable Solution | PSN | 4bab505d-d5c8-8c3b-e063-6394a90ad18a | 1 |
| 1666372 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection | SCD | 4bab505d-d5c8-8c3b-e063-6394a90ad18a | 1 |
| 1232651 | phenylephrine hydrochloride 10 MG/ML Injectable Solution | SCD | 4bab505d-d5c8-8c3b-e063-6394a90ad18a | 1 |
| 1666372 | phenylephrine HCl 10 MG per 1 ML Injection | SY | 4bab505d-d5c8-8c3b-e063-6394a90ad18a | 1 |
| 1232651 | phenylephrine hydrochloride 1 % Injectable Solution | SY | 4bab505d-d5c8-8c3b-e063-6394a90ad18a | 1 |
| 1232651 | phenylephrine hydrochloride 100 MG per 10 ML Injectable Solution | SY | 4bab505d-d5c8-8c3b-e063-6394a90ad18a | 1 |
| 1232651 | phenylephrine hydrochloride 50 MG per 5 ML Injectable Solution | SY | 4bab505d-d5c8-8c3b-e063-6394a90ad18a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58657-853-01 | 58657085301 | 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (58657-853-01) | 10 ml | 2026-02-01 | No | No | Current |