Phentolamine Mesylate
- Product NDC
- 0143-9564
- 11-digit product format
- 001439564
- Labeler code
- 0143
- Product ID
- 0143-9564_264ee71e-7e33-4693-b993-8ee0cc2f8d48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentolamine Mesylate
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA040235
- Marketing category
- ANDA
- Marketing start
- 1998-05-15
- Substance
- PHENTOLAMINE MESYLATE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phentolamine Mesylate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENTOLAMINE MESYLATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Y7543E5K9T |
| Rxcui | 1361023 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9564-01 | Phentolamine Mesylate | 1 in 1 BOX | INJECTION, POWDER, FOR SOLUTION | 1 | | 9 |
| 0143-9564-01 | Phentolamine Mesylate | 1 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 1 | | 9 |
| 0143-9564-10 | Phentolamine Mesylate | 1 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 1 | | 9 |
| 0143-9564-10 | Phentolamine Mesylate | 10 in 1 BOX | INJECTION, POWDER, FOR SOLUTION | 10 | | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9564 | PHENTOLAMINE MESYLATE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240316_ed6c506c-5535-4b7c-ae1a-d63f09d796c9.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 |
|---|
| 0143-9564-01 | 00143956401 | 1 VIAL in 1 BOX (0143-9564-01) / 1 mL in 1 VIAL | 1 vial | 2015-11-04 | 0000-00-00 | No | No | Current |
| 0143-9564-10 | 00143956410 | 10 VIAL in 1 BOX (0143-9564-10) / 1 mL in 1 VIAL | 10 vial | 2015-11-04 | 0000-00-00 | No | No | Current |