Phenylephrine hydrochloride
- Product NDC
- 70121-1577
- 11-digit product format
- 701211577
- Labeler code
- 70121
- Product ID
- 70121-1577_afc3a900-5704-4744-9e6b-0fe0a8fd0119
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA211079
- Marketing category
- ANDA
- Marketing start
- 2018-07-07
- 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 | 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 |
|---|---|---|---|---|---|---|
| 70121-1577-1 | Phenylephrine hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | 7 | |
| 70121-1577-5 | Phenylephrine hydrochloride | 25 in 1 CARTON | INJECTION | 25 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70121-1577-1 | ML - Milliliter | 70121-1577 | aa525265-10c9-48af-94ef-d247b65649c8 | 1 | 2018-11-06 |
| 70121-1577-5 | ML - Milliliter | 70121-1577 | 33aaa170-c63c-4e51-bbb7-bb8df6b8db64 | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70121-1577 | PHENYLEPHRINE HYDROCHLORIDE INJECTION [AMNEAL PHARMACEUTICALS LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240129_fad93be4-32dd-44c1-a20f-2b0bb3b41929.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1666372 | phenylephrine HCl 10 MG in 1 ML Injection | PSN | fad93be4-32dd-44c1-a20f-2b0bb3b41929 | 7 |
| 1666372 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection | SCD | fad93be4-32dd-44c1-a20f-2b0bb3b41929 | 7 |
| 1666372 | phenylephrine HCl 10 MG per 1 ML Injection | SY | fad93be4-32dd-44c1-a20f-2b0bb3b41929 | 7 |
| 1666372 | phenylephrine HCl 10 MG in 1 ML Injection | PSN | 6d59ee85-08e5-452d-a09a-35fcc2a82b75 | 5 |
| 1666372 | phenylephrine HCl 10 MG in 1 ML Injection | PSN | db313f72-a6bb-444f-949f-19b4aa6f61c0 | 5 |
| 1666372 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection | SCD | 6d59ee85-08e5-452d-a09a-35fcc2a82b75 | 5 |
| 1666372 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection | SCD | db313f72-a6bb-444f-949f-19b4aa6f61c0 | 5 |
| 1666372 | phenylephrine HCl 10 MG per 1 ML Injection | SY | 6d59ee85-08e5-452d-a09a-35fcc2a82b75 | 5 |
| 1666372 | phenylephrine HCl 10 MG per 1 ML Injection | SY | db313f72-a6bb-444f-949f-19b4aa6f61c0 | 5 |
| 1666372 | phenylephrine HCl 10 MG in 1 ML Injection | PSN | 86abb371-3ac9-9f74-e053-2991aa0a66af | 2 |
| 1666372 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection | SCD | 86abb371-3ac9-9f74-e053-2991aa0a66af | 2 |
| 1666372 | phenylephrine HCl 10 MG per 1 ML Injection | SY | 86abb371-3ac9-9f74-e053-2991aa0a66af | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70121-1577-1 | 70121157701 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | Historical | ||||
| 70121-1577-5 | 70121157705 | 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1577-5) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1577-1) | 2018-07-07 | 0000-00-00 | No | No | Current |