FDA.reportPublic FDA data

Fentanyl Citrate

Product NDC
63323-806
11-digit product format
633230806
Labeler code
63323
Product ID
63323-806_341b092a-1f6f-40f1-98f2-9346bf2e1242
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl Citrate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA210762
Marketing category
ANDA
Marketing start
2019-05-03
Substance
FENTANYL CITRATE
Active strength
.05 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fentanyl Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENTANYL CITRATE.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMUN5LYG46H
Rxcui1735003, 1735007, 1735008, 1735013, 2168270

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
63323-806-01Fentanyl Citrate25 in 1 CARTONINJECTION, SOLUTION2510
63323-806-02Fentanyl Citrate25 in 1 CARTONINJECTION, SOLUTION2510
63323-806-05Fentanyl Citrate25 in 1 CARTONINJECTION, SOLUTION2510
63323-806-11Fentanyl Citrate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION110
63323-806-12Fentanyl Citrate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION210
63323-806-13Fentanyl Citrate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION510
63323-806-14Fentanyl Citrate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2010
63323-806-20Fentanyl Citrate25 in 1 CARTONINJECTION, SOLUTION2510
63323-806-50Fentanyl Citrate1 in 1 CARTONINJECTION, SOLUTION110
63323-806-50Fentanyl Citrate50 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-806-01ML - Milliliter63323-806ba33c6c8-7bbd-46d4-a8df-3d0e29c04c2f12019-06-19
63323-806-02ML - Milliliter63323-806c4977484-18fb-4462-9777-373bcf1584a512019-06-19
63323-806-05ML - Milliliter63323-8065eb72e36-1e29-456c-b338-091e6f493cf912019-06-19
63323-806-11ML - Milliliter63323-8063de1a984-a2c7-42f3-9082-56f3fdc2686712019-06-19
63323-806-12ML - Milliliter63323-806950624f2-d41a-4e51-9de9-331efa4fe68d12019-06-19
63323-806-13ML - Milliliter63323-806234bad2d-1193-4119-b4b9-5f2821c13ed412019-06-19
63323-806-14ML - Milliliter63323-806052287a8-8eac-45d2-a494-fda8e5fc84ec12019-06-19
63323-806-20ML - Milliliter63323-8067b2210b0-9604-4d06-9913-db548e1fcde412019-06-19
63323-806-50ML - Milliliter63323-8063e6467f7-83c5-4732-ab9c-54b2f80b6f8612019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-806FENTANYL CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]10Current NDC, Legacy NDC, 10 package rows20250202_38d0c14a-a0c1-44cc-a939-0304eb8037d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1735003fentaNYL citrate 100 MCG in 2 ML InjectionPSN38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735008fentaNYL citrate 1000 MCG in 20 ML InjectionPSN38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735007fentaNYL citrate 250 MCG in 5 ML InjectionPSN38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735013fentaNYL citrate 2500 MCG in 50 ML InjectionPSN38d0c14a-a0c1-44cc-a939-0304eb8037d610
2168270fentaNYL citrate 50 MCG in 1 ML InjectionPSN38d0c14a-a0c1-44cc-a939-0304eb8037d610
21682701 ML fentanyl 0.05 MG/ML InjectionSCD38d0c14a-a0c1-44cc-a939-0304eb8037d610
17350032 ML fentanyl 0.05 MG/ML InjectionSCD38d0c14a-a0c1-44cc-a939-0304eb8037d610
173500820 ML fentanyl 0.05 MG/ML InjectionSCD38d0c14a-a0c1-44cc-a939-0304eb8037d610
17350075 ML fentanyl 0.05 MG/ML InjectionSCD38d0c14a-a0c1-44cc-a939-0304eb8037d610
173501350 ML fentanyl 0.05 MG/ML InjectionSCD38d0c14a-a0c1-44cc-a939-0304eb8037d610
2168270fentanyl (as fentanyl citrate) 50 MCG/ML per 1 ML InjectionSY38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735003fentanyl (as fentanyl citrate) 50 MCG/ML per 2 ML InjectionSY38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735008fentanyl (as fentanyl citrate) 50 MCG/ML per 20 ML InjectionSY38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735007fentanyl (as fentanyl citrate) 50 MCG/ML per 5 ML InjectionSY38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735013fentanyl (as fentanyl citrate) 50 MCG/ML per 50 ML InjectionSY38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735003fentanyl citrate 100 MCG per 2 ML InjectionSY38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735008fentanyl citrate 1000 MCG per 20 ML InjectionSY38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735007fentanyl citrate 250 MCG per 5 ML InjectionSY38d0c14a-a0c1-44cc-a939-0304eb8037d610
1735013fentanyl citrate 2500 MCG per 50 ML InjectionSY38d0c14a-a0c1-44cc-a939-0304eb8037d610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-806-016332308060125 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-806-11) 2019-05-030000-00-00NoNoCurrent
63323-806-026332308060225 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-806-12) 2019-05-030000-00-00NoNoCurrent
63323-806-056332308060525 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-806-13) 2019-05-030000-00-00NoNoCurrent
63323-806-11633230806111 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-806-12633230806122 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
63323-806-13633230806135 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
63323-806-146332308061420 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-806-206332308062025 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-806-14) 2019-05-030000-00-00NoNoCurrent
63323-806-50633230806501 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-50) / 50 mL in 1 VIAL, SINGLE-DOSE2019-05-030000-00-00NoNoCurrent