FDA.reportPublic FDA data

PAPAVERINE HYDROCHLORIDE

Product NDC
54288-142
Requested package NDC
54288-142-25
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54288-14254288-142-25UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54288-14254288-142-25UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54288-14254288-142-25UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
6f16f2ed-8e1c-4c6f-bd1d-846e02b1be97Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
54288-142-102025-02-11PAPAVERINE 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.
54288-142-252025-02-11PAPAVERINE 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.
54288-142-102025-01-30PAPAVERINE 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.
54288-142-252025-01-30PAPAVERINE 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

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 HYDROCHLORIDEBPI Labs LLC6f16f2ed-8e1c-4c6f-bd1d-846e02b1be972025-12-26Adverse reactionsExact identifier
ndc (package): 54288-142-25
ndc (product): 54288-142
ndc11 (package): 54288014225

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 startSampleExclude flagStatus
54288-142-255428801422525 VIAL in 1 CARTON (54288-142-25) / 2 mL in 1 VIAL (54288-142-01) 25 vial2023-04-26NoNoCurrent