Home NDC 67457-852 Norepinephrine bitartrate
Product NDC 67457-852
11-digit product format 674570852
Labeler code 67457
Product ID 67457-852_af3a6bd3-bbc9-43a9-a277-b55ae59d5097
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norepinephrine bitartrate
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA211242
Marketing category ANDA
Marketing start 2018-10-15
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 A211242-001 NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211242-001 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 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211242-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2018-10-04 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 2026-12-31 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 67457-852-00 Norepinephrine bitartrate 4 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 4 4 67457-852-04 Norepinephrine bitartrate 10 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-852 NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC] 4 Current NDC, Legacy NDC, 2 package rows 20231129_d3ea12e0-88cc-49b0-b06e-5199ecd6ca69.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 67457-852-00 67457085200 4 mL in 1 VIAL, SINGLE-DOSE 4 ml Historical 67457-852-04 67457085204 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-852-04) / 4 mL in 1 VIAL, SINGLE-DOSE (67457-852-00) 2018-10-15 0000-00-00 No No Current