Home NDC 0703-1153-83 Norepinephrine Bitartrate
Product NDC 0703-1153
Requested package NDC 0703-1153-83
11-digit product format 007031153
Labeler code 0703
Product ID 0703-1153_aba51a00-171e-4dc6-93c2-8e99cdeb8edf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norepinephrine Bitartrate
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA040455
Marketing category ANDA
Marketing start 2021-06-01
Marketing end 0000-00-00
Substance NOREPINEPHRINE BITARTRATE
Active strength 1 mg/mL
Pharmacologic classes Catecholamine [EPC],Catecholamines [CS]
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 · 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 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…2022-10-28 04:53 UTC 2022-10 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040455-001 NOREPINEPHRINE BITARTRATE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2003-03-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NOREPINEPHRINE BITARTRATE ACTIVE INGREDIENT IFY5PE3ZRW NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 4 NOREPINEPHRINE ACTIVE MOIETY X4W3ENH1CV NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 4 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 4
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 Marketing end Sample Exclude flag Status 0703-1153-83 00703115383 10 VIAL, SINGLE-USE in 1 CARTON (0703-1153-83) > 4 mL in 1 VIAL, SINGLE-USE (0703-1153-81) 2021-06-01 0000-00-00 No No Current