FDA.reportPublic FDA data

PAPAVERINE HYDROCHLORIDE

Product NDC
54288-142
11-digit product format
542880142
Labeler code
54288
Product ID
54288-142_afdd82fd-269d-4d51-b3f1-515ce7ead96d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Papaverine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; PARENTERAL
Labeler
BPI Labs LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-07-10
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54288-142-102025-02-11C16284748780-12cef2736-8ca4-d83d-e063-dadaa90ab31fPAPAVERINE HYDROCHLORIDE INJECTION, USP Rx Only This product is to be used by or under the direction of a physician. Each vial contains a sufficient amount to permit withdrawal and administration of the volume specified on the label.
54288-142-252025-02-11C16284748780-12cef2736-8ca4-d83d-e063-dadaa90ab31fPAPAVERINE HYDROCHLORIDE INJECTION, USP Rx Only This product is to be used by or under the direction of a physician. Each vial contains a sufficient amount to permit withdrawal and administration of the volume specified on the label.
54288-142-102025-01-30C16284748780-12cef2736-8ca4-d83d-e063-dadaa90ab31fPAPAVERINE HYDROCHLORIDE INJECTION, USP Rx Only This product is to be used by or under the direction of a physician. Each vial contains a sufficient amount to permit withdrawal and administration of the volume specified on the label.
54288-142-252025-01-30C16284748780-12cef2736-8ca4-d83d-e063-dadaa90ab31fPAPAVERINE HYDROCHLORIDE INJECTION, USP Rx Only This product is to be used by or under the direction of a physician. Each vial contains a sufficient amount to permit withdrawal and administration of the volume specified on the label.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-142-01PAPAVERINE HYDROCHLORIDE2 mL in 1 VIALINJECTION, SOLUTION29
54288-142-10PAPAVERINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION109
54288-142-25PAPAVERINE HYDROCHLORIDE25 in 1 CARTONINJECTION, SOLUTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-142-01ML - Milliliter54288-1426eb04eca-f26b-4dc0-a150-e0cb0b08071112021-08-05
54288-142-10ML - Milliliter54288-14220dd0777-f271-4694-b000-d354ca76d6d312021-08-05
54288-142-25ML - Milliliter54288-14249a29eb0-d4c2-4435-8489-83c3d51d9ead12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-142PAPAVERINE HYDROCHLORIDE INJECTION, SOLUTION [BPI LABS LLC]8Current NDC, Legacy NDC, 3 package rows20250213_6f16f2ed-8e1c-4c6f-bd1d-846e02b1be97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1789947papaverine HCl 60 MG in 2 ML InjectionPSN6f16f2ed-8e1c-4c6f-bd1d-846e02b1be979
17899472 ML papaverine hydrochloride 30 MG/ML InjectionSCD6f16f2ed-8e1c-4c6f-bd1d-846e02b1be979
1789947papaverine HCl 60 MG per 2 ML InjectionSY6f16f2ed-8e1c-4c6f-bd1d-846e02b1be979
1789947papaverine hydrochloride 60 MG per 2 ML InjectionSY6f16f2ed-8e1c-4c6f-bd1d-846e02b1be979

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54288-142-01542880142012 mL in 1 VIAL2 mlHistorical
54288-142-105428801421010 VIAL in 1 CARTON (54288-142-10) / 2 mL in 1 VIAL (54288-142-01) 10 vial2021-07-100000-00-00NoNoCurrent
54288-142-255428801422525 VIAL in 1 CARTON (54288-142-25) / 2 mL in 1 VIAL (54288-142-01) 25 vial2023-04-26NoNoHistorical