FDA.reportPublic FDA data

Abstral

Product NDC
57881-338
11-digit product format
578810338
Labeler code
57881
Product ID
57881-338_621fd88b-b921-47a2-94bd-a778d6005353
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fentanyl citrate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Galena Biopharma, Inc.
Application
NDA022510
Marketing category
NDA
Marketing start
2013-08-08
Marketing end
0000-00-00
Substance
FENTANYL CITRATE
Active strength
800 ug/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3Product name120231002
a8df478d-5b88-9654-981b-87dff14dda8bProduct name220190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57Product name220180118
bb365072-425e-ca0a-021e-fd8b78162502Product name220161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6Product name220160104
739fa0ac-b690-63c4-9904-e20dffbf78f9Product name120140508
7763fcbb-367d-ed06-b37f-e1529b6241beProduct name120140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57881-338-322020-01-31C16284748780-19d75b9d0-85c0-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
57881-338-04Abstral4 in 1 BLISTER PACKTABLET42
57881-338-32Abstral8 in 1 CARTONTABLET82

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57881-338-04EA - Each57881-3388857f829-a362-4c47-bb8d-85b0df5cc2b412013-11-04
57881-338-32EA - Each57881-338be84b28b-bff6-43bc-82d2-2cd6220a997c12013-11-04

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57881-338ABSTRAL (FENTANYL CITRATE) TABLET [GALENA BIOPHARMA, INC.]2Legacy NDC, 2 package rows20150114_f969e2bc-6297-4e29-89d3-a3685a2c7c6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053651ABSTRAL 100 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053654ABSTRAL 200 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053657ABSTRAL 300 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053660ABSTRAL 400 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053663ABSTRAL 600 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053666ABSTRAL 800 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053647fentaNYL 100 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053652fentaNYL 200 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053655fentaNYL 300 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053658fentaNYL 400 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053661fentaNYL 600 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053664fentaNYL 800 MCG Sublingual TabletPSNf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053651fentanyl 0.1 MG Sublingual Tablet [Abstral]SBDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053654fentanyl 0.2 MG Sublingual Tablet [Abstral]SBDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053657fentanyl 0.3 MG Sublingual Tablet [Abstral]SBDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053660fentanyl 0.4 MG Sublingual Tablet [Abstral]SBDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053663fentanyl 0.6 MG Sublingual Tablet [Abstral]SBDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053666fentanyl 0.8 MG Sublingual Tablet [Abstral]SBDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053647fentanyl 0.1 MG Sublingual TabletSCDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053652fentanyl 0.2 MG Sublingual TabletSCDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053655fentanyl 0.3 MG Sublingual TabletSCDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053658fentanyl 0.4 MG Sublingual TabletSCDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053661fentanyl 0.6 MG Sublingual TabletSCDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053664fentanyl 0.8 MG Sublingual TabletSCDf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053651Abstral (as fentanyl citrate) 100 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053654Abstral (as fentanyl citrate) 200 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053657Abstral (as fentanyl citrate) 300 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053660Abstral (as fentanyl citrate) 400 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053663Abstral (as fentanyl citrate) 600 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053666Abstral (as fentanyl citrate) 800 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053651Abstral 0.1 MG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053654Abstral 0.2 MG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053657Abstral 0.3 MG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053660Abstral 0.4 MG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053663Abstral 0.6 MG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053666Abstral 0.8 MG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053647fentanyl (as fentanyl citrate) 100 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053652fentanyl 200 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053655fentanyl 300 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053658fentanyl 400 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053661fentanyl 600 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2
1053664fentanyl 800 MCG Sublingual TabletSYf969e2bc-6297-4e29-89d3-a3685a2c7c6b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
57881-338-04578810338044 in 1 BLISTER PACKHistorical
57881-338-32578810338328 in 1 CARTONHistorical