FDA.reportPublic FDA data

Fentanyl Citrate

Product NDC
72572-170
11-digit product format
725720170
Labeler code
72572
Product ID
72572-170_220059dc-6b80-436d-8e75-1db03cd0d01b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl Citrate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
NDA019101
Marketing category
NDA
Marketing start
2019-12-10
Substance
FENTANYL CITRATE
Active strength
50 ug/mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fentanyl Citrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENTANYL CITRATE50 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMUN5LYG46H
Rxcui1735003, 1735007, 1735013

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-170-01Fentanyl Citrate2 mL in 1 VIALINJECTION213
72572-170-25Fentanyl Citrate25 in 1 CARTONINJECTION2513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-170-01ML - Milliliter72572-17040e9f451-eb9a-44ae-836c-b455abfe696d12020-01-03
72572-170-25ML - Milliliter72572-170580fb003-e33e-4b81-ac6f-370bb9b0dcd612020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-170FENTANYL CITRATE INJECTION [CIVICA, INC.]10Current NDC, Legacy NDC, 2 package rows20250406_aacf276b-e133-4199-ad3f-67b894744c04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1735003fentaNYL citrate 100 MCG in 2 ML InjectionPSNaacf276b-e133-4199-ad3f-67b894744c0413
1735007fentaNYL citrate 250 MCG in 5 ML InjectionPSNaacf276b-e133-4199-ad3f-67b894744c0413
1735013fentaNYL citrate 2500 MCG in 50 ML InjectionPSNaacf276b-e133-4199-ad3f-67b894744c0413
17350032 ML fentanyl 0.05 MG/ML InjectionSCDaacf276b-e133-4199-ad3f-67b894744c0413
17350075 ML fentanyl 0.05 MG/ML InjectionSCDaacf276b-e133-4199-ad3f-67b894744c0413
173501350 ML fentanyl 0.05 MG/ML InjectionSCDaacf276b-e133-4199-ad3f-67b894744c0413
1735003fentanyl (as fentanyl citrate) 50 MCG/ML per 2 ML InjectionSYaacf276b-e133-4199-ad3f-67b894744c0413
1735007fentanyl (as fentanyl citrate) 50 MCG/ML per 5 ML InjectionSYaacf276b-e133-4199-ad3f-67b894744c0413
1735013fentanyl (as fentanyl citrate) 50 MCG/ML per 50 ML InjectionSYaacf276b-e133-4199-ad3f-67b894744c0413
1735003fentanyl citrate 100 MCG per 2 ML InjectionSYaacf276b-e133-4199-ad3f-67b894744c0413
1735007fentanyl citrate 250 MCG per 5 ML InjectionSYaacf276b-e133-4199-ad3f-67b894744c0413
1735013fentanyl citrate 2500 MCG per 50 ML InjectionSYaacf276b-e133-4199-ad3f-67b894744c0413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-170-01725720170012 mL in 1 VIAL2 mlHistorical
72572-170-257257201702525 VIAL in 1 CARTON (72572-170-25) / 2 mL in 1 VIAL (72572-170-01) 25 vial2019-12-100000-00-00NoNoCurrent