Biorphen
- Product NDC
- 43598-172
- 11-digit product format
- 435980172
- Labeler code
- 43598
- Product ID
- 43598-172_884b0378-92e0-f3ed-176b-ff409f29747f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenylephrine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- NDA212909
- Marketing category
- NDA
- Marketing start
- 2022-11-25
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- .1 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
- Biorphen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | .1 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 04JA59TNSJ |
| Rxcui | 1666372, 2262018, 2533434, 2533437 |
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 |
|---|---|---|---|---|---|---|
| 43598-172-05 | Biorphen | 5 mL in 1 AMPULE | INJECTION, SOLUTION | 5 | 5 | |
| 43598-172-15 | Biorphen | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 5 | |
| 43598-172-25 | Biorphen | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43598-172-05 | ML - Milliliter | 43598-172 | 402af37d-007d-4f08-9954-934986d1bb96 | 1 | 2023-01-09 |
| 43598-172-15 | ML - Milliliter | 43598-172 | ce85ab85-9287-4743-b76e-624ad1961f4a | 1 | 2023-01-09 |
| 43598-172-25 | ML - Milliliter | 43598-172 | ee1f84e7-98d0-4104-8069-cb4188372f17 | 1 | 2024-06-10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2533437 | Biorphen 10 MG in 1 ML Injection | PSN | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 2533434 | Biorphen 500 MCG in 5 mL Injection | PSN | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 1666372 | phenylephrine HCl 10 MG in 1 ML Injection | PSN | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 2262018 | phenylephrine hydrochloride 500 MCG in 5 mL Injection | PSN | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 2533437 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection [Biorphen] | SBD | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 2533434 | 5 ML phenylephrine hydrochloride 0.1 MG/ML Injection [Biorphen] | SBD | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 1666372 | 1 ML phenylephrine hydrochloride 10 MG/ML Injection | SCD | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 2262018 | 5 ML phenylephrine hydrochloride 0.1 MG/ML Injection | SCD | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 2533434 | Biorphen 0.1 MG/ML per 5 ML Injection | SY | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 2533437 | Biorphen 10 MG per 1 ML Injection | SY | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 2533434 | Biorphen 500 MCG per 5 ML Injection | SY | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 1666372 | phenylephrine HCl 10 MG per 1 ML Injection | SY | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
| 2262018 | phenylephrine hydrochloride 500 MCG per 5 ML Injection | SY | 2f715e4e-b269-b935-d2c9-003cb29770be | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43598-172-05 | 43598017205 | 5 mL in 1 AMPULE | 5 ml | Historical | ||||
| 43598-172-15 | 43598017215 | 10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05) | 10 ampule | 2022-11-25 | 0000-00-00 | No | No | Current |
| 43598-172-25 | 43598017225 | 5 mL in 1 VIAL (43598-172-25) | 5 ml | 2024-05-10 | No | No | Current |