Home NDC 0362-0101 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022159-001 ORAVERSE PHENTOLAMINE MESYLATE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022159-001 ORAVERSE 0.4MG/1.7ML INJECTABLE / INJECTION RLD, RS 2008-05-09 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 3 · 90 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022159-001 NPP 2019-03-18 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022159-001 NPP 2019-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022159-001 NPP 2019-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022159-001 NPP 2019-03-18 ea99ee380514…
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y7543E5K9T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361019 Internal RxNorm lookup 1361021 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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