Home NDC 68094-101 PHENTOLAMINE MESYLATE
Product NDC 68094-101
11-digit product format 680940101
Labeler code 68094
Product ID 68094-101_4ecf4179-a773-4f75-a48b-a0b2c51facc2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PHENTOLAMINE MESYLATE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Precision Dose Inc.
Application ANDA207686
Marketing category ANDA
Marketing start 2017-07-15
Substance PHENTOLAMINE MESYLATE
Active strength 5 mg/1
Pharmacologic classes Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A207686-001 PHENTOLAMINE MESYLATE PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207686-001 AP
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207686-001 PHENTOLAMINE MESYLATE 5MG/VIAL INJECTABLE / INJECTION AP 2017-07-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1361023 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68094-101 PHENTOLAMINE MESYLATE INJECTION [PRECISION DOSE INC.] 12 Current NDC, Legacy NDC 20240823_e146c7ee-d2fa-433c-8768-0945e4ff0990.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 68094-101-10 68094010110 10 CARTON in 1 TRAY (68094-101-10) > 1 VIAL in 1 CARTON (68094-101-20) > 1 INJECTION in 1 VIAL 10 carton 2017-07-15 0000-00-00 No No Current 68094-101-20 68094010120 1 VIAL in 1 CARTON (68094-101-20) / 1 INJECTION in 1 VIAL 1 vial 2017-07-15 No No Current