Oraverse
- Product NDC
- 0362-0101
- 11-digit product format
- 003620101
- Labeler code
- 0362
- Product ID
- 0362-0101_f0465990-acce-46dc-9290-344dab1e4f2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentolamine Mesylate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Septodont, Inc.
- Application
- NDA022159
- Marketing category
- NDA
- Marketing start
- 2011-06-01
- Substance
- PHENTOLAMINE MESYLATE
- Active strength
- .235 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
- Oraverse
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENTOLAMINE MESYLATE | .235 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Y7543E5K9T |
| Rxcui | 1361019, 1361021 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0362-0101-10 | Oraverse | 1.7 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.7 | | 4 |
| 0362-0101-10 | Oraverse | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Phentolamine Mesylate | ACTIVE INGREDIENT | Y7543E5K9T | ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 1 | |
| Phentolamine | ACTIVE MOIETY | Z468598HBV | ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 1 | |
| Acetic Acid | INACTIVE INGREDIENT | Q40Q9N063P | ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 1 | |
| Mannitol | INACTIVE INGREDIENT | 3OWL53L36A | ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 1 | |
| Nitrogen | INACTIVE INGREDIENT | N762921K75 | ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 1 | |
| Sodium Acetate | INACTIVE INGREDIENT | 4550K0SC9B | ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0362-0101 | ORAVERSE (PHENTOLAMINE MESYLATE) INJECTION, SOLUTION [SEPTODONT, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20181206_4025cf98-ea87-4531-b0fc-6283c84f63f3.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 |
|---|
| 0362-0101-10 | 00362010110 | 10 CARTRIDGE in 1 CARTON (0362-0101-10) / 1.7 mL in 1 CARTRIDGE | 10 cartridge | 2011-06-01 | 0000-00-00 | No | No | Current |