Home NDC 51224-012-10 Phentolamine Mesylate
Product NDC 51224-012
Requested package NDC 51224-012-10
11-digit product format 512240012
Labeler code 51224
Product ID 51224-012_f70b960c-7d8d-4b87-8b5a-57cbcda74af0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phentolamine Mesylate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler TAGI Pharma, Inc.
Application ANDA207686
Marketing category ANDA
Marketing start 2017-07-15
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51224-012 51224-012-10 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51224-012 51224-012-10 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51224-012 PHENTOLAMINE MESYLATE INJECTION [TAGI PHARMA, INC.] 7 Legacy NDC 20250503_fe1e10f5-4ff3-4616-9534-489648d88d33.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51224-012-10 51224001210 10 CARTON in 1 TRAY (51224-012-10) > 1 VIAL in 1 CARTON (51224-012-20) > 1 INJECTION in 1 VIAL 10 carton 2017-07-15 0000-00-00 No No Current