Home NDC 51662-1528 NOREPINEPHRINE BITARTRATE
Product NDC 51662-1528
11-digit product format 516621528
Labeler code 51662
Product ID 51662-1528_0ff8ef97-006a-e6ca-e063-6294a90a2365
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NOREPINEPHRINE BITARTRATE
Dosage form INJECTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA203662
Marketing category ANDA
Marketing start 2021-08-08
Substance NOREPINEPHRINE BITARTRATE
Active strength 1 mg/mL
Pharmacologic classes Catecholamine [EPC], Catecholamines [CS]
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 A203662-001 NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203662-001 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 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203662-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-11-07 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 NOREPINEPHRINE BITARTRATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NOREPINEPHRINE BITARTRATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IFY5PE3ZRW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242969 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 51662-1528-1 NOREPINEPHRINE BITARTRATE 4 mL in 1 VIAL INJECTION 4 3 51662-1528-2 NOREPINEPHRINE BITARTRATE 1 in 1 POUCH INJECTION 1 3 51662-1528-2 NOREPINEPHRINE BITARTRATE 4 mL in 1 VIAL INJECTION 4 3 51662-1528-3 NOREPINEPHRINE BITARTRATE 10 in 1 CASE INJECTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1528 NOREPINEPHRINE BITARTRATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, Legacy NDC, 4 package rows 20240129_c90d875c-8e6e-284e-e053-2a95a90a334f.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 · 2 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 51662-1528-1 51662152801 4 mL in 1 VIAL (51662-1528-1) 4 ml 2021-08-08 0000-00-00 No No Current 51662-1528-2 51662152802 1 in 1 POUCH Historical 51662-1528-3 51662152803 10 POUCH in 1 CASE (51662-1528-3) / 1 VIAL in 1 POUCH (51662-1528-2) / 4 mL in 1 VIAL 10 pouch 2022-07-10 0000-00-00 No No Current