FDA.reportPublic FDA data

NOREPINEPHRINE BITARTRATE

Product NDC
83854-017
Requested package NDC
83854-017-10
11-digit product format
838540017
Labeler code
83854
Product ID
83854-017_44791190-e870-ac45-e063-6294a90acaa9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NOREPINEPHRINE BITARTRATE
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Anthea Pharma Private Limited
Application
ANDA219924
Marketing category
ANDA
Marketing start
2025-11-25
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219924-001NOREPINEPHRINE BITARTRATENOREPINEPHRINE BITARTRATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2025-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A219924-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219924-001NOREPINEPHRINE BITARTRATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2025-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219924-001NOREPINEPHRINE BITARTRATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2025-11-2531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219924-001NOREPINEPHRINE BITARTRATEEQ 1MG BASE/MLINJECTABLE / INJECTIONAP2025-11-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219924-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219924-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219924-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
NOREPINEPHRINE BITARTRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NOREPINEPHRINE BITARTRATE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IFY5PE3ZRWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242969Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52e22892-4fc3-4f53-9f39-0b5c66da3040Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ab36713-99a4-1d04-c42f-907afc73b6f9Product name720260105
209a4db0-2639-413d-9ad3-274ad7be11f7Product name120230912
08ddeef6-6d79-428b-a00b-432b50fc2b32Product name120230831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83854-017-01NOREPINEPHRINE BITARTRATE4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE43
83854-017-10NOREPINEPHRINE BITARTRATE10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE103

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
norepinephrine bitartrateNOREPINEPHRINE BITARTRATEAvenacy, LLCdd4b7827-2fe9-4427-a40a-60f275611bf42026-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219924
application number: ANDA219924
NOREPINEPHRINE BITARTRATENOREPINEPHRINE BITARTRATEAnthea Pharma Private Limited52e22892-4fc3-4f53-9f39-0b5c66da30402025-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219924
application number: ANDA219924
ndc (package): 83854-017-10
ndc (product): 83854-017
ndc11 (package): 83854001710

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSN52e22892-4fc3-4f53-9f39-0b5c66da30403
2429694 ML norepinephrine 1 MG/ML InjectionSCD52e22892-4fc3-4f53-9f39-0b5c66da30403
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSY52e22892-4fc3-4f53-9f39-0b5c66da30403
242969norepinephrine 4 MG per 4 ML InjectionSY52e22892-4fc3-4f53-9f39-0b5c66da30403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83854-017-108385400171010 VIAL in 1 CARTON (83854-017-10) / 4 mL in 1 VIAL (83854-017-01) 10 vial2025-11-25NoNoCurrent