FDA.reportPublic FDA data

Papaverine Hydrochloride

Product NDC
72516-024
11-digit product format
725160024
Labeler code
72516
Product ID
72516-024_2b4bd8c6-2b93-d435-e063-6394a90ae742
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Papaverine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Oryza Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-02-01
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
72516-024-102023-02-09C16284748780-1f386c64a-2a67-0266-e053-dadaa90a7c1aPAPAVERINE HYDROCHLORIDE INJECTION, USP
72516-024-252023-02-09C16284748780-1f386c64a-2a67-0266-e053-dadaa90a7c1aPAPAVERINE HYDROCHLORIDE INJECTION, USP
72516-024-102023-01-30C16284748780-1f386c64a-2a67-0266-e053-dadaa90a7c1aPAPAVERINE HYDROCHLORIDE INJECTION, USP
72516-024-252023-01-30C16284748780-1f386c64a-2a67-0266-e053-dadaa90a7c1aPAPAVERINE HYDROCHLORIDE INJECTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72516-024-10Papaverine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION24
72516-024-10Papaverine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION104
72516-024-25Papaverine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION254
72516-024-25Papaverine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72516-024-10ML - Milliliter72516-02482eea6e5-2bf3-481e-a984-26226ef2ab0312021-03-02
72516-024-25ML - Milliliter72516-0249837d4ad-4bc7-4f9a-842c-1f4503f7cc4b12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72516-024PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [ORYZA PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 4 package rows20250115_5ba6e650-a5b5-4381-a62a-b7a6df73e8e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1789947papaverine HCl 60 MG in 2 ML InjectionPSN5ba6e650-a5b5-4381-a62a-b7a6df73e8e64
17899472 ML papaverine hydrochloride 30 MG/ML InjectionSCD5ba6e650-a5b5-4381-a62a-b7a6df73e8e64
1789947papaverine HCl 60 MG per 2 ML InjectionSY5ba6e650-a5b5-4381-a62a-b7a6df73e8e64
1789947papaverine hydrochloride 60 MG per 2 ML InjectionSY5ba6e650-a5b5-4381-a62a-b7a6df73e8e64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72516-024-107251600241010 VIAL in 1 CARTON (72516-024-10) / 2 mL in 1 VIAL10 vial2021-02-010000-00-00NoNoCurrent
72516-024-257251600242525 VIAL in 1 CARTON (72516-024-25) / 2 mL in 1 VIAL25 vial2021-02-010000-00-00NoNoCurrent