Biorphen
- Product NDC
- 71863-203
- 11-digit product format
- 718630203
- Labeler code
- 71863
- Product ID
- 71863-203_38e86f03-06e1-4921-91de-529ca54d9af6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eton Pharmaceuticals, Inc.
- Application
- NDA212909
- Marketing category
- NDA
- Marketing start
- 2021-03-11
- Marketing end
- 0000-00-00
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|
| 71863-203-01 | Biorphen | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | 11 | |
| 71863-203-02 | Biorphen | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 11 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2533437 | Biorphen 10 MG in 1 ML Injection | PSN | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 2533434 | Biorphen 500 MCG in 5 mL Injection | PSN | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 1666372 | phenylephrine HCl 10 MG in 1 ML Injection | PSN | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 2262018 | phenylephrine hydrochloride 500 MCG in 5 mL Injection | PSN | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 2533437 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection [Biorphen] | SBD | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 2533434 | 5 ML phenylephrine hydrochloride 0.1 MG/ML Injection [Biorphen] | SBD | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 1666372 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection | SCD | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 2262018 | 5 ML phenylephrine hydrochloride 0.1 MG/ML Injection | SCD | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 2533434 | Biorphen 0.1 MG/ML per 5 ML Injection | SY | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 2533437 | Biorphen 10 MG per 1 ML Injection | SY | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 2533434 | Biorphen 500 MCG per 5 ML Injection | SY | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 1666372 | phenylephrine HCl 10 MG per 1 ML Injection | SY | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
| 2262018 | phenylephrine hydrochloride 500 MCG per 5 ML Injection | SY | bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71863-203-01 | 71863020301 | 1 mL in 1 AMPULE | 1 ml | Historical | ||||
| 71863-203-02 | 71863020302 | 10 AMPULE in 1 CARTON (71863-203-02) > 1 mL in 1 AMPULE (71863-203-01) | 10 ampule | 2021-03-11 | 0000-00-00 | No | No | Current |