FDA.reportPublic FDA data

NDC 54288-142-01 - PAPAVERINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54288-142
Requested NDC
54288-142-01
Package NDCs from labels
54288-142-01, 54288-142-10, 54288-142-25
Manufacturer
BPI Labs LLC
Effective date
2025-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PAPAVERINE HYDROCHLORIDE - BPI Labs LLCBPI Labs LLC2025-12-26HUMAN PRESCRIPTION DRUG LABEL

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 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 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

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 8 of 20 · 387 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrogenNITROGENAll Gas & Welding Supplies Co., Inc.f43540c0-741c-78c3-e053-2995a90aa2d42025-11-18Exact identifier
unii: N762921K75
NitrogenNITROGENA & B Welding Supply Co.d8143272-2594-f3f4-e053-2a95a90abf6e2025-11-18Exact identifier
unii: N762921K75
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NitrogenNITROGENRoberts Oxygen Company, Inc273511c2-2b84-4373-a0e5-3961eb19af8c2025-11-17Exact identifier
unii: N762921K75
NitrogenNITROGENRoberts Oxygen Company, Inc863f2711-582f-4ccb-aae8-9bb18fa4df532025-11-17Exact identifier
unii: N762921K75
NitrogenNITROGENRoberts Oxygen Company, Inc.2bed6bd8-086e-ee30-e063-6394a90ad4202025-11-17Exact identifier
unii: N762921K75
NitrogenNITROGENDelille Oxygen Companyb82f163b-c913-431d-88cf-8b6e08d1b42a2025-11-17Exact identifier
unii: N762921K75
NITROGENNITROGENKeen Compressed Gas Co. Inc.ce23d008-6b12-4937-9b87-fea423ac49a82025-11-17Exact identifier
unii: N762921K75
NITROGENNITROGENHolston Gases, Incad17ae2e-033c-4bb0-804b-538f9350a09f2025-11-14Exact identifier
unii: N762921K75
NITROGENNITROGENSuperior Welding Supply Co8c3be9ad-0e95-43db-924d-d31ccea61f892025-11-14Exact identifier
unii: N762921K75
NitrogenNITROGENGeneral Distributing Companye2ee1489-0037-42ed-8fb3-0a566e3a2c342025-11-14Exact identifier
unii: N762921K75
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
unii: 2968PHW8QP
NitrogenNITROGENHelget Gas Productsf791daf6-244b-0546-e053-6294a90acffc2025-11-12Exact identifier
unii: N762921K75
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
NitrogenNITROGENBaker's Gas & Welding Supplies Inc.7a2b122f-b115-4f75-bd50-00a14036aad02025-11-11Exact identifier
unii: N762921K75
AQUACETIC-30CLEANING SOLUTION FOR HEMODIALYSIS MACHINESAqua Medica, S.A. de C.V.040775ab-41bd-cd36-e063-6394a90a08aa2025-11-10WarningsExact identifier
unii: 2968PHW8QP
CITRACID-50DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINEAqua Medica, S.A. de C.V.040713e7-67cd-8eb0-e063-6394a90aa2a92025-11-10WarningsExact identifier
unii: 2968PHW8QP
NitrogenNITROGENENCORE WELDING AND INDUSTRIAL SUPPLY LLC9f560df0-5c3f-d06a-e053-2a95a90a3e5c2025-11-07Exact identifier
unii: N762921K75
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.