Home NDC 72603-806 Norepinephrine Bitartrate
Product NDC 72603-806
11-digit product format 726030806
Labeler code 72603
Product ID 72603-806_2e6ab5d2-1717-454e-96bd-93a2d24ee037
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norepinephrine Bitartrate
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Northstar Rx LLC
Application ANDA040455
Marketing category ANDA
Marketing start 2026-10-30
Substance NOREPINEPHRINE BITARTRATE
Active strength 1 mg/mL
Pharmacologic classes Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A040455-001 NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040455-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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 Marketing start Sample Exclude flag Status 72603-806-10 72603080610 10 VIAL, SINGLE-USE in 1 CARTON (72603-806-10) / 4 mL in 1 VIAL, SINGLE-USE (72603-806-01) 2026-10-30 No No Current