Home NDC 51662-1567-1 COSYNTROPIN
Product NDC 51662-1567
Requested package NDC 51662-1567-1
11-digit product format 516621567
Labeler code 51662
Product ID 51662-1567_120401a8-c1c7-581c-e063-6294a90a94f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COSYNTROPIN
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA202147
Marketing category ANDA
Marketing start 2021-07-10
Substance COSYNTROPIN
Active strength .25 mg/mL
Pharmacologic classes Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [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 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 A202147-001 COSYNTROPIN COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202147-001 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 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202147-001 COSYNTROPIN 0.25MG/VIAL INJECTABLE / INJECTION AP 2012-06-29 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 COSYNTROPIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COSYNTROPIN .25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 72YY86EA29 Internal UNII 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 51662-1567-1 COSYNTROPIN 1 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1567 COSYNTROPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 2 Current NDC, Legacy NDC, 1 package rows 20240224_c6cf2223-4a93-0b28-e053-2a95a90ade53.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 · 3 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 51662-1567-1 51662156701 1 mL in 1 VIAL (51662-1567-1) 1 ml 2021-07-10 0000-00-00 No No Current