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)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|---|---|
| 1 | 525330024 | UNAPPROVED DRUG OTHER MARKETING CATEGORY | Cantrell Drug Company | 2011-07-26, 2012-01-23, 2012-04-12, 2012-04-13, 2012-08-14, 2012-09-04, 2013-01-30, 2013-04-23, 2013-10-11, 2014-08-06 | FENTANYL CITRATE | INTRAVENOUS | INJECTION, SOLUTION | 119881aa-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)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|---|---|
| 1 | 525330025 | UNAPPROVED DRUG OTHER MARKETING CATEGORY | Cantrell Drug Company | 2013-01-30, 2014-08-13, 2014-08-21 | FENTANYL CITRATE | INTRAVENOUS | INJECTION, SOLUTION | 9622cd81-1387-41c5-a42d-469d2e757629, f936818a-b0bd-4811-b9b8-3fa9620a7379, f98ebc12-05ac-4777-9eb5-642fb8124b50 |
fentanyl 0.025 mg/ml injectable solution
product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|---|---|
| 1 | 525330026 | UNAPPROVED DRUG OTHER MARKETING CATEGORY | Cantrell Drug Company | 2012-10-19, 2013-03-25, 2013-08-27, 2014-08-21 | FENTANYL CITRATE | INTRAVENOUS | INJECTION, SOLUTION | 2e325659-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)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004099094 | NDA | Hospira, Inc. | 1985-01-12 | FENTANYL CITRATE | INTRAMUSCULAR | INJECTION, SOLUTION | NDA019115 | bfa8018a-4cbc-434b-e09e-782872b0340a |
| 2 | 006416025 | NDA | West-Ward Pharmaceuticals Corp. | 1984-07-11 | FENTANYL CITRATE | INTRAMUSCULAR | INJECTION | NDA019101 | ce5db1c2-feb1-4ad2-847a-d02e865bd47e |
| 3 | 006416026 | NDA | West-Ward Pharmaceuticals Corp. | 1984-07-11 | FENTANYL CITRATE | INTRAVENOUS | INJECTION | NDA019101 | ce5db1c2-feb1-4ad2-847a-d02e865bd47e |
| 4 | 006416029 | NDA | West-Ward Pharmaceuticals Corp. | 1984-07-11 | FENTANYL CITRATE | INTRAVENOUS | INJECTION | NDA019101 | ce5db1c2-feb1-4ad2-847a-d02e865bd47e |
| 5 | 100190035 | NDA | Baxter Healthcare Corporation | 2010-06-25 | FENTANYL CITRATE | INTRAMUSCULAR | INJECTION, SOLUTION | NDA019101 | 8c630f74-906d-47a5-8e41-3334df191cb0 |
| 6 | 100190038 | NDA | Baxter Healthcare Corporation | 2010-06-25 | FENTANYL CITRATE | INTRAMUSCULAR | INJECTION, SOLUTION | NDA019101 | 8c630f74-906d-47a5-8e41-3334df191cb0 |
| 7 | 174780030 | NDA | Akorn | 2012-03-22 | FENTANYL CITRATE | INTRAMUSCULAR | INJECTION | NDA016619 | c5d40297-b769-48cc-9f84-f98b7a333507 |
| 8 | 525330074 | UNAPPROVED DRUG OTHER MARKETING CATEGORY | Cantrell Drug Company | 2011-10-20 | FENTANYL CITRATE | INTRAMUSCULAR | INJECTION, SOLUTION | 207c3e4b-2cf0-41d8-82c3-caa21553edd4, 58c3bcc5-4e6b-4cb9-9912-940a664e9d71, 73cede3f-aff0-40b8-8a58-f5fc269d1b8d |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA070636 | FENTANYL CITRATE | True | ABBOTT LABORATORIES HOSP PRODUCTS DIV | 1990-04-30 | ANDA070636_001 | Fentanyl Prefilled Syringe |
| 2 | ANDA070637 | FENTANYL CITRATE | True | ABBOTT LABORATORIES HOSP PRODUCTS DIV | 1990-04-30 | ANDA070637_001 | Fentanyl Prefilled Syringe |
| 3 | ANDA072786 | FENTANYL CITRATE PRESERVATIVE FREE | HOSPIRA INC | 1991-09-24 | ANDA072786_001 | Fentanyl Prefilled Syringe | |
| 4 | ANDA073488 | FENTANYL CITRATE | True | WATSON LABORATORIES INC | 1992-06-30 | ANDA073488_001 | Fentanyl Prefilled Syringe |
| 5 | ANDA074917 | FENTANYL CITRATE PRESERVATIVE FREE | True | WATSON LABORATORIES INC | 1998-02-03 | ANDA074917_001 | Fentanyl Prefilled Syringe |
| 6 | NDA016619 | SUBLIMAZE PRESERVATIVE FREE | AKORN INC | NDA016619_001 | Fentanyl Prefilled Syringe | ||
| 7 | NDA019101 | FENTANYL CITRATE PRESERVATIVE FREE | EUROHEALTH INTERNATIONAL SARL | 1984-07-11 | NDA019101_001 | Fentanyl Prefilled Syringe | |
| 8 | NDA019115 | FENTANYL CITRATE | HOSPIRA INC | 1985-01-12 | NDA019115_001 | Fentanyl Prefilled Syringe |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA070636_001 | discontinued | FENTANYL CITRATE (EQ 0.05MG BASE/ML) | INJECTION | False | 1990-04-30 | FENTANYL CITRATE | |
| 2 | ANDA070637_001 | discontinued | FENTANYL CITRATE (EQ 0.05MG BASE/ML) | INJECTION | False | 1990-04-30 | FENTANYL CITRATE | |
| 3 | ANDA072786_001 | RX | FENTANYL CITRATE (EQ 0.05MG BASE/ML) | INJECTION | False | AP | 1991-09-24 | FENTANYL CITRATE PRESERVATIVE FREE |
| 4 | ANDA073488_001 | discontinued | FENTANYL CITRATE (EQ 0.05MG BASE/ML) | INJECTION | False | 1992-06-30 | FENTANYL CITRATE | |
| 5 | ANDA074917_001 | discontinued | FENTANYL CITRATE (EQ 0.05MG BASE/ML) | INJECTION | False | 1998-02-03 | FENTANYL CITRATE PRESERVATIVE FREE | |
| 6 | NDA016619_001 | RX | FENTANYL CITRATE (EQ 0.05MG BASE/ML) | INJECTION | True | AP | SUBLIMAZE PRESERVATIVE FREE | |
| 7 | NDA019101_001 | RX | FENTANYL CITRATE (EQ 0.05MG BASE/ML) | INJECTION | True | AP | 1984-07-11 | FENTANYL CITRATE PRESERVATIVE FREE |
| 8 | NDA019115_001 | RX | FENTANYL CITRATE (EQ 0.05MG BASE/ML) | INJECTION | False | AP | 1985-01-12 | FENTANYL CITRATE |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 119881aa-f508-455e-9fdb-6444ccce2d56 (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 60 mL Bag | prescription | Human Prescription | Cantrell Drug Company | 2014-04-09 | 4 | 525330024 | |
| 2 | 1bc95d37-9d10-4c6c-88a3-bb83d937b268 (view SPL) | Fentanyl Citrate 50 mcg/mL in 0.9% Sodium Chloride 30 mL Monoject Syringe Barrel | prescription | Human Prescription | Cantrell Drug Company | 2014-04-30 | 3 | 525330116 | |
| 3 | 207c3e4b-2cf0-41d8-82c3-caa21553edd4 (view SPL) | Fentanyl Citrate 50 mcg/mL in Sterile Water 20 mL Syringe | prescription | Human Prescription | Cantrell Drug Company | 2014-04-30 | 6 | 525330074 | |
| 4 | 262fde40-115d-4d8a-b044-643128fff56b (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 100 mL Bag | prescription | Human Prescription | Cantrell Drug Company | 2013-04-23 | 1 | 525330024 | |
| 5 | 2e325659-b551-4fb0-b5fc-302de211596b (view SPL) | Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial | prescription | Human Prescription | Cantrell Drug Company | 2013-04-05 | 1 | 525330026 | |
| 6 | 4ebe41a0-539a-4914-85ff-3971e994785f (view SPL) | Fentanyl Citrate 50 mcg/mL in 0.9% Sodium Chloride 100 mL Bag | prescription | Human Prescription | Cantrell Drug Company | 2013-03-14 | 1 | 525330116 | |
| 7 | 58c3bcc5-4e6b-4cb9-9912-940a664e9d71 (view SPL) | Fentanyl Citrate 50 mcg/mL in Sterile Water 5 mL Syringe | prescription | Human Prescription | Cantrell Drug Company | 2014-05-02 | 5 | 525330074 | |
| 8 | 62752ca3-060e-430b-a05c-40c89ee5df1d (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 1 mL Syringe | prescription | Human Prescription | Cantrell Drug Company | 2014-05-02 | 5 | 525330024 | |
| 9 | 62f80157-f1d7-4d4a-b88a-117fe3285da1 (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial | prescription | Human Prescription | Cantrell Drug Company | 2014-08-06 | 4 | 525330024 | |
| 10 | 6f57b24b-b0ce-4d6a-b533-26ef4b9a20b1 (view SPL) | Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet | prescription | Human Prescription | Cantrell Drug Company | 2013-04-05 | 2 | 525330026 | |
| 11 | 73cede3f-aff0-40b8-8a58-f5fc269d1b8d (view SPL) | Fentanyl Citrate 50 mcg/mL in Sterile Water 2 mL Syringe | prescription | Human Prescription | Cantrell Drug Company | 2014-05-02 | 5 | 525330074 | |
| 12 | 7b01f652-6ee8-4bf1-b311-6e1c75356284 (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 250 mL Bag | prescription | Human Prescription | Cantrell Drug Company | 2014-08-06 | 6 | 525330024 | |
| 13 | 898706aa-203a-497b-9ac2-8a3728d955d8 (view SPL) | Fentanyl Citrate 50 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet | prescription | Human Prescription | Cantrell Drug Company | 2014-04-09 | 3 | 525330116 | |
| 14 | 8c630f74-906d-47a5-8e41-3334df191cb0 (view SPL) | Fentanyl Citrate Injection, USPCIIRx only | prescription | Human Prescription | Baxter Healthcare Corporation | MANUFACTURE | 2010-07-15 | 3 | 100190035, 100190038, 100190033, 100190037 |
| 15 | 8f0aa19c-825a-435e-8b72-4e39a5c9e226 (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet | prescription | Human Prescription | Cantrell Drug Company | 2014-08-06 | 1 | 525330024 | |
| 16 | 9622cd81-1387-41c5-a42d-469d2e757629 (view SPL) | Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial | prescription | Human Prescription | Cantrell Drug Company | 2013-04-05 | 1 | 525330025 | |
| 17 | 972f6cbc-32e3-4ef1-b644-94f79ff23a95 (view SPL) | Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 50 mL Syringe | prescription | Human Prescription | Cantrell Drug Company | 2014-04-29 | 4 | 525330026 | |
| 18 | a2603cb4-a700-420e-aee5-58f6838567ab (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 100 mL Bag | prescription | Human Prescription | Cantrell Drug Company | manufacture | 2012-10-09 | 1 | 525330024 |
| 19 | a7d7e065-8089-4951-bd39-71e9963672d5 (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 150 mL Bag | prescription | Human Prescription | Cantrell Drug Company | 2014-08-13 | 5 | 525330024 | |
| 20 | bb940c9d-99c0-4a6e-941e-4bc91d9d3628 (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 100 mL Bag | prescription | Human Prescription | Cantrell Drug Company | 2012-08-29 | 1 | 525330024 | |
| 21 | bde24a8c-526d-4246-acfa-ea2b95e8a5fb (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 50 mL Syringe | prescription | Human Prescription | Cantrell Drug Company | 2014-08-13 | 7 | 525330024 | |
| 22 | bfa8018a-4cbc-434b-e09e-782872b0340a (view SPL) | FENTANYL CITRATE Injection, USPRx only 50 mcg (0.05 mg) fentanyl/mL | prescription | Human Prescription | Hospira, Inc. | 2014-10-07 | 11 | 004099094, 004099093 | |
| 23 | c5d40297-b769-48cc-9f84-f98b7a333507 (view SPL) | Fentanyl Citrate Injection, USP CII | prescription | Human Prescription | Akorn | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2013-07-11 | 3 | 174780030 |
| 24 | ce5db1c2-feb1-4ad2-847a-d02e865bd47e (view SPL) | Fentanyl Citrate Injection, USP | prescription | Human Prescription | West-Ward Pharmaceuticals Corp. | ANALYSIS, LABEL, MANUFACTURE | 2011-12-09 | 1 | 006416025, 006416026, 006416029, 006416024, 006416027, 006416028, 006416030 |
| 25 | cef7cd9f-c665-4fba-88aa-325e63ecf384 (view SPL) | Fentanyl Citrate 50 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial | prescription | Human Prescription | Cantrell Drug Company | 2014-08-13 | 4 | 525330116 | |
| 26 | da928672-4144-4ec4-93ba-e466f2a4a7e4 (view SPL) | Fentanyl Citrate 10 mcg/mL in 0.9% Sodium Chloride 250 mL Bag | prescription | Human Prescription | Cantrell Drug Company | 2014-08-13 | 5 | 525330024 | |
| 27 | dfd161c2-a2e2-437c-abb5-5c33d87da31c (view SPL) | Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 55 mL Syringe | prescription | Human Prescription | Cantrell Drug Company | 2014-08-13 | 4 | 525330026 | |
| 28 | f936818a-b0bd-4811-b9b8-3fa9620a7379 (view SPL) | Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet | prescription | Human Prescription | Cantrell Drug Company | 2014-08-06 | 1 | 525330025 | |
| 29 | f98ebc12-05ac-4777-9eb5-642fb8124b50 (view SPL) | Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 100 mL Bag | prescription | Human Prescription | Cantrell Drug Company | 2013-05-15 | 3 | 525330025 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII