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 9 of 20 · 387 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NITROGENNITROGENAGP LLC8e922dd4-c6ea-4ef6-9e26-35c599e8135b2025-11-04Exact identifier
unii: N762921K75
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NitrogenNITROGENAndy-Oxy Co., Inc.2914edb9-b3e3-4407-8be3-3e830f710e742025-10-30Exact identifier
unii: N762921K75
NitrogenNITROGENRaimy Corporation2990d4f3-a582-21cb-e063-6394a90a6c002025-10-30Exact identifier
unii: N762921K75
NitrogenNITROGENRaimy Corporation9af1adde-4612-2b8d-e053-2a95a90a8c882025-10-30Exact identifier
unii: N762921K75
NitrogenNITROGENILMO Products Company7e0f2f4a-ac52-412c-97c6-0b4c44bdb5a52025-10-29Exact identifier
unii: N762921K75
NitrogenNITROGEN801576526754a7d13-973f-42ed-87fa-3ef5d5f90bec2025-10-29Exact identifier
unii: N762921K75
NitrogenNITROGENGeer Gas Corporation98bf51e7-01bb-e3f7-e053-2995a90a42f02025-10-29Exact identifier
unii: N762921K75
NitrogenNITROGENJ & M CYLINDER GASES, INC.9af277a4-04f6-0805-e053-2a95a90a78c82025-10-29Exact identifier
unii: N762921K75
NITROGENNITROGENANALGESIC SERVICES, INC.c15972b6-24af-4f5a-a244-7c155d5cc4a92025-10-29Exact identifier
unii: N762921K75
NitrogenNITROGENToll Company07dcb683-a5e9-b016-e063-6394a90a746d2025-10-29Exact identifier
unii: N762921K75
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NITROGENNITROGENClinical 1 Home Medical, Inc.4d7413b3-74f7-4439-91ab-bef2c3f27fda2025-10-28Exact identifier
unii: N762921K75
NitrogenNITROGENAero All Gas Companyfadb4118-fc02-4c66-aa7a-cf78a861602e2025-10-28Exact identifier
unii: N762921K75
NitrogenNITROGENC & C Oxygen Company32d9050e-dc65-48b9-bfee-b914d38481272025-10-28Exact identifier
unii: N762921K75
NitrogenNITROGENCentral Welding Supply Companyb0bee448-ad4c-4538-8caf-72706370fad12025-10-28Exact identifier
unii: N762921K75
NitrogenNITROGENFresno Oxygen & Welding Suppliers Inc80929f9d-93c1-430d-aba3-cdf99b2abd722025-10-28Exact identifier
unii: N762921K75
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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