FDA.reportPublic FDA data

Papaverine Hydrochloride

Product NDC
14789-121
11-digit product format
147890121
Labeler code
14789
Product ID
14789-121_28dc648b-5306-8daf-e063-6294a90a9b44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Papaverine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Nexus Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-06-28
Substance
PAPAVERINE HYDROCHLORIDE
Active strength
30 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Papaverine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAPAVERINE HYDROCHLORIDE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
23473EC6BQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1789947Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e76839f-82eb-42a8-abc2-e7fbc533082dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14789-121-052023-02-01C16284748780-1f386c649-c553-0266-e053-dadaa90a7c1aPAPAVERINE HYDROCHLORIDE INJECTION, USP
14789-121-052023-01-30C16284748780-1f386c649-c553-0266-e053-dadaa90a7c1aPAPAVERINE HYDROCHLORIDE INJECTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14789-121-05Papaverine Hydrochloride10 in 1 CARTONINJECTION105
14789-121-07Papaverine Hydrochloride2 mL in 1 VIAL, SINGLE-USEINJECTION25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14789-121-05ML - Milliliter14789-12141e50347-ec38-4a1c-9556-f4e6c7feb90f12021-09-07
14789-121-07ML - Milliliter14789-121362d1a42-2b36-49eb-a10c-5975614d64cf12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14789-121PAPAVERINE HYDROCHLORIDE INJECTION [NEXUS PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20241211_1e76839f-82eb-42a8-abc2-e7fbc533082d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Papaverine HydrochloridePAPAVERINE HYDROCHLORIDENexus Pharmaceuticals, LLC1e76839f-82eb-42a8-abc2-e7fbc533082d2024-12-09Adverse reactionsExact identifier
ndc (product): 14789-121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1789947papaverine HCl 60 MG in 2 ML InjectionPSN1e76839f-82eb-42a8-abc2-e7fbc533082d5
17899472 ML papaverine hydrochloride 30 MG/ML InjectionSCD1e76839f-82eb-42a8-abc2-e7fbc533082d5
1789947papaverine HCl 60 MG per 2 ML InjectionSY1e76839f-82eb-42a8-abc2-e7fbc533082d5
1789947papaverine hydrochloride 60 MG per 2 ML InjectionSY1e76839f-82eb-42a8-abc2-e7fbc533082d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14789-121-051478901210510 VIAL, SINGLE-USE in 1 CARTON (14789-121-05) / 2 mL in 1 VIAL, SINGLE-USE (14789-121-07) 2021-06-280000-00-00NoNoCurrent
14789-121-07147890121072 mL in 1 VIAL, SINGLE-USE2 mlHistorical