FDA.reportPublic FDA data

NDC 57881-331-04 - Abstral

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
57881-331
Requested NDC
57881-331-04
Package NDCs from labels
57881-331-04, 57881-331-32
Manufacturer
Galena Biopharma, Inc. | Pharmaceutics International, Inc.
Effective date
2014-11-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Abstral - Galena Biopharma, Inc. | Pharmaceutics International, Inc.Galena Biopharma, Inc. | Pharmaceutics International, Inc.2014-11-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57881-331-322020-01-31C16284748780-19d75b9d0-85c0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL. ABSTRAL ® (fentanyl) sublingual tablets CII Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57881-331-04Abstral4 in 1 BLISTER PACKTABLET42
57881-331-32Abstral8 in 1 CARTONTABLET82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57881-331ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]2Legacy NDC, 2 package rows20150114_f969e2bc-6297-4e29-89d3-a3685a2c7c6b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57881-331-04EA - Each57881-331040a8fdf-0848-4b43-8f6f-e9e138031eef12013-11-04
57881-331-32EA - Each57881-3319d90cc22-4c57-4a7e-8021-afc34394d28d12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fentanyl citrateACTIVE INGREDIENTMUN5LYG46HABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]2
fentanylACTIVE MOIETYUF599785JZABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36AABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]2

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fentanyl CitrateFENTANYL CITRATEHospira, Inc.bfa8018a-4cbc-434b-e09e-782872b0340a2026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
FENTANYL CITRATEFENTANYL CITRATEHospira, Inc.1ed25b2c-334e-4021-ada1-3396f07630dc2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
Fentanyl CitrateFENTANYL CITRATEHikma Pharmaceuticals USA Inc.ce5db1c2-feb1-4ad2-847a-d02e865bd47e2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
Fentanyl CitrateFENTANYL CITRATECivica, Inc.aacf276b-e133-4199-ad3f-67b894744c042025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
Fentanyl CitrateFENTANYL CITRATEPhlow Corp.58dcd3f7-e3d8-4929-a186-8f680a51ff112025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
Fentanyl CitrateFENTANYL CITRATEHikma Pharmaceuticals USA Inc.c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b72025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Fentanyl CitrateFENTANYL CITRATEFresenius Kabi USA, LLC0c10e465-4117-48ba-a454-23ccb7a3fcc72025-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Fentanyl CitrateFENTANYL CITRATEFresenius Kabi USA, LLC38d0c14a-a0c1-44cc-a939-0304eb8037d62024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MUN5LYG46H
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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