Biorphen
- Product NDC
- 43598-199
- 11-digit product format
- 435980199
- Labeler code
- 43598
- Product ID
- 43598-199_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
- 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
- Biorphen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04JA59TNSJ |
| Rxcui | 1666372, 2262018, 2533434, 2533437 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-199-01 | Biorphen | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | | 5 |
| 43598-199-10 | Biorphen | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-199 | BIORPHEN (PHENYLEPHRINE HYDROCHLORIDE) INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240502_2f715e4e-b269-b935-d2c9-003cb29770be.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-199-01 | 43598019901 | 1 mL in 1 AMPULE | 1 ml | | | | | Historical |
| 43598-199-10 | 43598019910 | 10 AMPULE in 1 CARTON (43598-199-10) / 1 mL in 1 AMPULE (43598-199-01) | 10 ampule | 2022-11-25 | 0000-00-00 | No | No | Current |