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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57881-331-32	2020-01-31	C162847	48780-1	9d75b9d0-85c0-f424-e053-dadaa90a57ce	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
57881-331-04	Abstral	4 in 1 BLISTER PACK	TABLET	4		2
57881-331-32	Abstral	8 in 1 CARTON	TABLET	8		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57881-331	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2	Legacy NDC, 2 package rows	20150114_f969e2bc-6297-4e29-89d3-a3685a2c7c6b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57881-331-04	EA - Each	57881-331	040a8fdf-0848-4b43-8f6f-e9e138031eef	1	2013-11-04
57881-331-32	EA - Each	57881-331	9d90cc22-4c57-4a7e-8021-afc34394d28d	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
fentanyl citrate	ACTIVE INGREDIENT	MUN5LYG46H	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2
fentanyl	ACTIVE MOIETY	UF599785JZ	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]	2
mannitol	INACTIVE INGREDIENT	3OWL53L36A	ABSTRAL (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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
621fd88b-b921-47a2-94bd-a778d6005353			f969e2bc-6297-4e29-89d3-a3685a2c7c6b	2014-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 621fd88b-b921-47a2-94bd-a778d6005353 spl set id: f969e2bc-6297-4e29-89d3-a3685a2c7c6b

Reported adverse events (FAERS/openFDA)#

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