Fentanyl Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-10-07)
Oldest Current Product
1984-07-11
License(s)
NDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\FENTANYL
FDAOB
INJECTION\INJECTION\FENTANYL CITRATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\FENTANYL CITRATE
INTRAMUSCULAR\INJECTION\FENTANYL CITRATE
INTRAVENOUS\INJECTION, SOLUTION\FENTANYL CITRATE
INTRAVENOUS\INJECTION\FENTANYL CITRATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\FENTANYL
INTRAMUSCULAR\INJECTION\FENTANYL
INTRAVENOUS\INJECTION, SOLUTION\FENTANYL
INTRAVENOUS\INJECTION\FENTANYL

product(s) by strength(s)

fentanyl 0.01 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330024UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2011-07-26, 2012-01-23, 2012-04-12, 2012-04-13, 2012-08-14, 2012-09-04, 2013-01-30, 2013-04-23, 2013-10-11, 2014-08-06FENTANYL CITRATEINTRAVENOUSINJECTION, SOLUTION119881aa-f508-455e-9fdb-6444ccce2d56, 262fde40-115d-4d8a-b044-643128fff56b, 62752ca3-060e-430b-a05c-40c89ee5df1d, 62f80157-f1d7-4d4a-b88a-117fe3285da1, 7b01f652-6ee8-4bf1-b311-6e1c75356284, 8f0aa19c-825a-435e-8b72-4e39a5c9e226, a2603cb4-a700-420e-aee5-58f6838567ab, a7d7e065-8089-4951-bd39-71e9963672d5, bb940c9d-99c0-4a6e-941e-4bc91d9d3628, bde24a8c-526d-4246-acfa-ea2b95e8a5fb, da928672-4144-4ec4-93ba-e466f2a4a7e4

fentanyl 0.02 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330025UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2013-01-30, 2014-08-13, 2014-08-21FENTANYL CITRATEINTRAVENOUSINJECTION, SOLUTION9622cd81-1387-41c5-a42d-469d2e757629, f936818a-b0bd-4811-b9b8-3fa9620a7379, f98ebc12-05ac-4777-9eb5-642fb8124b50

fentanyl 0.025 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330026UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2012-10-19, 2013-03-25, 2013-08-27, 2014-08-21FENTANYL CITRATEINTRAVENOUSINJECTION, SOLUTION2e325659-b551-4fb0-b5fc-302de211596b, 6f57b24b-b0ce-4d6a-b533-26ef4b9a20b1, 972f6cbc-32e3-4ef1-b644-94f79ff23a95, dfd161c2-a2e2-437c-abb5-5c33d87da31c

fentanyl 0.05 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004099094NDAHospira, Inc.1985-01-12FENTANYL CITRATEINTRAMUSCULARINJECTION, SOLUTIONNDA019115bfa8018a-4cbc-434b-e09e-782872b0340a
2006416025NDAWest-Ward Pharmaceuticals Corp.1984-07-11FENTANYL CITRATEINTRAMUSCULARINJECTIONNDA019101ce5db1c2-feb1-4ad2-847a-d02e865bd47e
3006416026NDAWest-Ward Pharmaceuticals Corp.1984-07-11FENTANYL CITRATEINTRAVENOUSINJECTIONNDA019101ce5db1c2-feb1-4ad2-847a-d02e865bd47e
4006416029NDAWest-Ward Pharmaceuticals Corp.1984-07-11FENTANYL CITRATEINTRAVENOUSINJECTIONNDA019101ce5db1c2-feb1-4ad2-847a-d02e865bd47e
5100190035NDABaxter Healthcare Corporation2010-06-25FENTANYL CITRATEINTRAMUSCULARINJECTION, SOLUTIONNDA0191018c630f74-906d-47a5-8e41-3334df191cb0
6100190038NDABaxter Healthcare Corporation2010-06-25FENTANYL CITRATEINTRAMUSCULARINJECTION, SOLUTIONNDA0191018c630f74-906d-47a5-8e41-3334df191cb0
7174780030NDAAkorn2012-03-22FENTANYL CITRATEINTRAMUSCULARINJECTIONNDA016619c5d40297-b769-48cc-9f84-f98b7a333507
8525330074UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2011-10-20FENTANYL CITRATEINTRAMUSCULARINJECTION, SOLUTION207c3e4b-2cf0-41d8-82c3-caa21553edd4, 58c3bcc5-4e6b-4cb9-9912-940a664e9d71, 73cede3f-aff0-40b8-8a58-f5fc269d1b8d

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070636FENTANYL CITRATETrueABBOTT LABORATORIES HOSP PRODUCTS DIV1990-04-30ANDA070636_001Fentanyl Prefilled Syringe
2ANDA070637FENTANYL CITRATETrueABBOTT LABORATORIES HOSP PRODUCTS DIV1990-04-30ANDA070637_001Fentanyl Prefilled Syringe
3ANDA072786FENTANYL CITRATE PRESERVATIVE FREEHOSPIRA INC1991-09-24ANDA072786_001Fentanyl Prefilled Syringe
4ANDA073488FENTANYL CITRATETrueWATSON LABORATORIES INC1992-06-30ANDA073488_001Fentanyl Prefilled Syringe
5ANDA074917FENTANYL CITRATE PRESERVATIVE FREETrueWATSON LABORATORIES INC1998-02-03ANDA074917_001Fentanyl Prefilled Syringe
6NDA016619SUBLIMAZE PRESERVATIVE FREEAKORN INCNDA016619_001Fentanyl Prefilled Syringe
7NDA019101FENTANYL CITRATE PRESERVATIVE FREEEUROHEALTH INTERNATIONAL SARL1984-07-11NDA019101_001Fentanyl Prefilled Syringe
8NDA019115FENTANYL CITRATEHOSPIRA INC1985-01-12NDA019115_001Fentanyl Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070636_001discontinuedFENTANYL CITRATE (EQ 0.05MG BASE/ML)INJECTIONFalse1990-04-30FENTANYL CITRATE
2ANDA070637_001discontinuedFENTANYL CITRATE (EQ 0.05MG BASE/ML)INJECTIONFalse1990-04-30FENTANYL CITRATE
3ANDA072786_001RXFENTANYL CITRATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP1991-09-24FENTANYL CITRATE PRESERVATIVE FREE
4ANDA073488_001discontinuedFENTANYL CITRATE (EQ 0.05MG BASE/ML)INJECTIONFalse1992-06-30FENTANYL CITRATE
5ANDA074917_001discontinuedFENTANYL CITRATE (EQ 0.05MG BASE/ML)INJECTIONFalse1998-02-03FENTANYL CITRATE PRESERVATIVE FREE
6NDA016619_001RXFENTANYL CITRATE (EQ 0.05MG BASE/ML)INJECTIONTrueAPSUBLIMAZE PRESERVATIVE FREE
7NDA019101_001RXFENTANYL CITRATE (EQ 0.05MG BASE/ML)INJECTIONTrueAP1984-07-11FENTANYL CITRATE PRESERVATIVE FREE
8NDA019115_001RXFENTANYL CITRATE (EQ 0.05MG BASE/ML)INJECTIONFalseAP1985-01-12FENTANYL CITRATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1119881aa-f508-455e-9fdb-6444ccce2d56 (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 60 mL BagprescriptionHuman PrescriptionCantrell Drug Company2014-04-094525330024
21bc95d37-9d10-4c6c-88a3-bb83d937b268 (view SPL)Fentanyl Citrate 50 mcg/mL in 0.9% Sodium Chloride 30 mL Monoject Syringe BarrelprescriptionHuman PrescriptionCantrell Drug Company2014-04-303525330116
3207c3e4b-2cf0-41d8-82c3-caa21553edd4 (view SPL)Fentanyl Citrate 50 mcg/mL in Sterile Water 20 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-04-306525330074
4262fde40-115d-4d8a-b044-643128fff56b (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 100 mL BagprescriptionHuman PrescriptionCantrell Drug Company2013-04-231525330024
52e325659-b551-4fb0-b5fc-302de211596b (view SPL)Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 30 mL PCA VialprescriptionHuman PrescriptionCantrell Drug Company2013-04-051525330026
64ebe41a0-539a-4914-85ff-3971e994785f (view SPL)Fentanyl Citrate 50 mcg/mL in 0.9% Sodium Chloride 100 mL BagprescriptionHuman PrescriptionCantrell Drug Company2013-03-141525330116
758c3bcc5-4e6b-4cb9-9912-940a664e9d71 (view SPL)Fentanyl Citrate 50 mcg/mL in Sterile Water 5 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-05-025525330074
862752ca3-060e-430b-a05c-40c89ee5df1d (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 1 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-05-025525330024
962f80157-f1d7-4d4a-b88a-117fe3285da1 (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 30 mL PCA VialprescriptionHuman PrescriptionCantrell Drug Company2014-08-064525330024
106f57b24b-b0ce-4d6a-b533-26ef4b9a20b1 (view SPL)Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2013-04-052525330026
1173cede3f-aff0-40b8-8a58-f5fc269d1b8d (view SPL)Fentanyl Citrate 50 mcg/mL in Sterile Water 2 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-05-025525330074
127b01f652-6ee8-4bf1-b311-6e1c75356284 (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 250 mL BagprescriptionHuman PrescriptionCantrell Drug Company2014-08-066525330024
13898706aa-203a-497b-9ac2-8a3728d955d8 (view SPL)Fentanyl Citrate 50 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2014-04-093525330116
148c630f74-906d-47a5-8e41-3334df191cb0 (view SPL)Fentanyl Citrate Injection, USPCIIRx onlyprescriptionHuman PrescriptionBaxter Healthcare CorporationMANUFACTURE2010-07-153100190035, 100190038, 100190033, 100190037
158f0aa19c-825a-435e-8b72-4e39a5c9e226 (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2014-08-061525330024
169622cd81-1387-41c5-a42d-469d2e757629 (view SPL)Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA VialprescriptionHuman PrescriptionCantrell Drug Company2013-04-051525330025
17972f6cbc-32e3-4ef1-b644-94f79ff23a95 (view SPL)Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 50 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-04-294525330026
18a2603cb4-a700-420e-aee5-58f6838567ab (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 100 mL BagprescriptionHuman PrescriptionCantrell Drug Companymanufacture2012-10-091525330024
19a7d7e065-8089-4951-bd39-71e9963672d5 (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 150 mL BagprescriptionHuman PrescriptionCantrell Drug Company2014-08-135525330024
20bb940c9d-99c0-4a6e-941e-4bc91d9d3628 (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 100 mL BagprescriptionHuman PrescriptionCantrell Drug Company2012-08-291525330024
21bde24a8c-526d-4246-acfa-ea2b95e8a5fb (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 50 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-08-137525330024
22bfa8018a-4cbc-434b-e09e-782872b0340a (view SPL)FENTANYL CITRATE Injection, USPRx only 50 mcg (0.05 mg) fentanyl/mLprescriptionHuman PrescriptionHospira, Inc.2014-10-0711004099094, 004099093
23c5d40297-b769-48cc-9f84-f98b7a333507 (view SPL)Fentanyl Citrate Injection, USP CIIprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-07-113174780030
24ce5db1c2-feb1-4ad2-847a-d02e865bd47e (view SPL)Fentanyl Citrate Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2011-12-091006416025, 006416026, 006416029, 006416024, 006416027, 006416028, 006416030
25cef7cd9f-c665-4fba-88aa-325e63ecf384 (view SPL)Fentanyl Citrate 50 mcg/mL in 0.9% Sodium Chloride 30 mL PCA VialprescriptionHuman PrescriptionCantrell Drug Company2014-08-134525330116
26da928672-4144-4ec4-93ba-e466f2a4a7e4 (view SPL)Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 250 mL BagprescriptionHuman PrescriptionCantrell Drug Company2014-08-135525330024
27dfd161c2-a2e2-437c-abb5-5c33d87da31c (view SPL)Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 55 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-08-134525330026
28f936818a-b0bd-4811-b9b8-3fa9620a7379 (view SPL)Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2014-08-061525330025
29f98ebc12-05ac-4777-9eb5-642fb8124b50 (view SPL)Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 100 mL BagprescriptionHuman PrescriptionCantrell Drug Company2013-05-153525330025

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII