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 Identifiers#

Field, Values table
FieldValues
Unii23473EC6BQ
Rxcui1789947

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

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