Ciprofloxacin Injection
- Brand(s)
- Cipro
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Bayer Healthcare Pharmaceuticals Inc. (2015-03-17)
- Oldest Current Product
- 2006-08-28
- License(s)
- NDA, ANDA
- RxNORM
- INJECTION\CIPROFLOXACIN
- FDAOB
- INJECTION\INJECTION\CIPROFLOXACIN\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\CIPROFLOXACIN
INTRAVENOUS\INJECTION, SOLUTION\CIPROFLOXACIN
INTRAVENOUS\INJECTION\CIPROFLOXACIN
INTRAVENOUS\SOLUTION, CONCENTRATE\CIPROFLOXACIN - SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\CIPROFLOXACIN
INTRAVENOUS\INJECTION, SOLUTION\CIPROFLOXACIN
INTRAVENOUS\INJECTION\CIPROFLOXACIN
INTRAVENOUS\SOLUTION, CONCENTRATE\CIPROFLOXACIN
product(s) by strength(s)
40 ml ciprofloxacin 10 mg/ml injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000693342 | ANDA | Pfizer Labs | 2009-09-11 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA078062 | 7217ffdd-bcd2-48b7-a397-da966ea533bd |
| 2 | 004094778 | ANDA | Hospira, Inc. | 2006-08-28 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA077245 | a341d31b-a011-457a-76a1-a96146d2924e |
| 3 | 360000011 | ANDA | Claris Lifesciences Inc. | 2009-09-17 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA078062 | e82f52f2-ecf8-4c04-a206-f3253b265903 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 216950914 | ANDA | Rebel Distributors Corp | 2009-12-08 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | 004094778 | ANDA077245 | d4730085-b38e-43ce-bb51-2532da0a3e2b |
20 ml ciprofloxacin 10 mg/ml injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000693241 | ANDA | Pfizer Labs | 2009-09-11 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA078062 | 7217ffdd-bcd2-48b7-a397-da966ea533bd |
| 2 | 004094765 | ANDA | Hospira, Inc. | 2006-08-28 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA077245 | a341d31b-a011-457a-76a1-a96146d2924e |
| 3 | 360000010 | ANDA | Claris Lifesciences Inc. | 2009-09-17 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | ANDA078062 | e82f52f2-ecf8-4c04-a206-f3253b265903 |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 216950422 | ANDA | Rebel Distributors Corp | 2006-08-28 | CIPROFLOXACIN | INTRAVENOUS | INJECTION | 007030956 | ANDA077782 | 19df63de-9f44-40ce-9a4f-0c96345b8a23 |
ciprofloxacin 2 mg/ml injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004094777 | ANDA | Hospira, Inc. | 2008-03-18 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION | ANDA077753 | 65fff92f-b51b-4f5e-20bd-b651e613578d, 9deb95f4-83a0-4928-a55d-41f7f02bb3f3 |
| 2 | 250210114 | ANDA | Sagent Pharmaceuticals | 2008-03-24 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION | ANDA078252 | 7049f870-6741-4a67-8033-398c36126a06 |
200 ml ciprofloxacin 2 mg/ml injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 504190759 | Cipro | NDA | Bayer Healthcare Pharmaceuticals Inc. | 2009-04-22 | CIPROFLOXACIN | INTRAVENOUS | SOLUTION, CONCENTRATE | NDA019857 | 457d7810-23f1-4318-9561-2cd58a9cf973 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000694396 | ANDA | Pfizer Labs | 2009-09-11 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION | ANDA078024 | 7217ffdd-bcd2-48b7-a397-da966ea533bd |
| 2 | 007813240 | ANDA | Sandoz Inc | 2008-03-24 | CIPROFLOXACIN | INTRAVENOUS | INJECTION | ANDA078252 | 231b60f5-4b72-4f8f-a19e-b7068a601c3a |
| 3 | 360000009 | ANDA | Claris Lifesciences Inc. | 2008-08-04 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION | ANDA078024 | e82f52f2-ecf8-4c04-a206-f3253b265903 |
| 4 | 360000030 | ANDA | Claris Lifesciences Inc. | 2012-10-23 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION | ANDA078024 | e82f52f2-ecf8-4c04-a206-f3253b265903 |
100 ml ciprofloxacin 2 mg/ml injection
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000694395 | ANDA | Pfizer Labs | 2009-09-11 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION | ANDA078024 | 7217ffdd-bcd2-48b7-a397-da966ea533bd |
| 2 | 007813239 | ANDA | Sandoz Inc | 2008-03-24 | CIPROFLOXACIN | INTRAVENOUS | INJECTION | ANDA078252 | 231b60f5-4b72-4f8f-a19e-b7068a601c3a |
| 3 | 360000008 | ANDA | Claris Lifesciences Inc. | 2008-08-04 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION | ANDA078024 | e82f52f2-ecf8-4c04-a206-f3253b265903 |
| 4 | 360000029 | ANDA | Claris Lifesciences Inc. | 2008-08-04 | CIPROFLOXACIN | INTRAVENOUS | INJECTION, SOLUTION | ANDA078024 | e82f52f2-ecf8-4c04-a206-f3253b265903 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA076484 | CIPROFLOXACIN | True | FRESENIUS KABI USA LLC | 2006-08-28 | ANDA076484_001, ANDA076484_002 |
| 2 | ANDA076717 | CIPROFLOXACIN | HIKMA FARMACEUTICA (PORTUGAL) SA | 2009-12-22 | ANDA076717_001, ANDA076717_002 | |
| 3 | ANDA076757 | CIPROFLOXACIN IN DEXTROSE 5% | True | HIKMA FARMACEUTICA (PORTUGAL) SA | 2008-04-21 | ANDA076757_001 |
| 4 | ANDA076992 | CIPROFLOXACIN | True | BEDFORD LABORATORIES | 2006-08-28 | ANDA076992_001, ANDA076992_002 |
| 5 | ANDA076993 | CIPROFLOXACIN | True | BEDFORD LABORATORIES | 2006-08-28 | ANDA076993_001 |
| 6 | ANDA077138 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | True | TEVA PHARMACEUTICALS USA | 2008-03-18 | ANDA077138_001, ANDA077138_002 |
| 7 | ANDA077245 | CIPROFLOXACIN | HOSPIRA INC | 2006-08-28 | ANDA077245_001, ANDA077245_002 | |
| 8 | ANDA077753 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | HOSPIRA INC | 2008-03-18 | ANDA077753_001, ANDA077753_002 | |
| 9 | ANDA077782 | CIPROFLOXACIN | True | TEVA PHARMACEUTICALS USA | 2006-08-28 | ANDA077782_001, ANDA077782_002 |
| 10 | ANDA077888 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | True | BAXTER HEALTHCARE CORP | 2008-03-18 | ANDA077888_001, ANDA077888_002 |
| 11 | ANDA078024 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CLARIS PHARMASERVICES | 2008-03-18 | ANDA078024_001, ANDA078024_002 | |
| 12 | ANDA078062 | CIPROFLOXACIN | CLARIS PHARMASERVICES | 2008-04-29 | ANDA078062_001, ANDA078062_002 | |
| 13 | ANDA078114 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | True | BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC | 2008-03-18 | ANDA078114_001, ANDA078114_002 |
| 14 | ANDA078252 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | ACS DOBFAR INFO SA | 2008-03-18 | ANDA078252_001, ANDA078252_002 | |
| 15 | ANDA078431 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | HIKMA FARMACEUTICA (PORTUGAL) SA | 2009-11-18 | ANDA078431_001 | |
| 16 | NDA019847 | CIPRO | BAYER HEALTHCARE PHARMACEUTICALS INC | 1990-12-26 | NDA019847_001, NDA019847_002, NDA019847_003 | |
| 17 | NDA019857 | CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER | BAYER HEALTHCARE PHARMACEUTICALS INC | 1990-12-26 | NDA019857_001, NDA019857_002 | |
| 18 | NDA019858 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | True | BAYER PHARMACEUTICALS CORP | 1990-12-26 | NDA019858_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA076484_001 | discontinued | CIPROFLOXACIN (200MG/20ML) | INJECTION | False | 2006-08-28 | CIPROFLOXACIN | |
| 2 | ANDA076484_002 | discontinued | CIPROFLOXACIN (400MG/40ML) | INJECTION | False | 2006-08-28 | CIPROFLOXACIN | |
| 3 | ANDA076717_001 | RX | CIPROFLOXACIN (200MG/20ML) | INJECTION | False | AP | 2009-12-22 | CIPROFLOXACIN |
| 4 | ANDA076717_002 | RX | CIPROFLOXACIN (400MG/40ML) | INJECTION | False | AP | 2009-12-22 | CIPROFLOXACIN |
| 5 | ANDA076757_001 | discontinued | CIPROFLOXACIN (200MG/100ML) | INJECTION | False | 2008-04-21 | CIPROFLOXACIN IN DEXTROSE 5% | |
| 6 | ANDA076992_001 | discontinued | CIPROFLOXACIN (200MG/20ML) | INJECTION | False | 2006-08-28 | CIPROFLOXACIN | |
| 7 | ANDA076992_002 | discontinued | CIPROFLOXACIN (400MG/40ML) | INJECTION | False | 2006-08-28 | CIPROFLOXACIN | |
| 8 | ANDA076993_001 | discontinued | CIPROFLOXACIN (1200MG/120ML) | INJECTION | False | 2006-08-28 | CIPROFLOXACIN | |
| 9 | ANDA077138_001 | discontinued | CIPROFLOXACIN (200MG/100ML) | INJECTION | False | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | |
| 10 | ANDA077138_002 | discontinued | CIPROFLOXACIN (400MG/200ML) | INJECTION | False | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | |
| 11 | ANDA077245_001 | RX | CIPROFLOXACIN (200MG/20ML) | INJECTION | False | AP | 2006-08-28 | CIPROFLOXACIN |
| 12 | ANDA077245_002 | RX | CIPROFLOXACIN (400MG/40ML) | INJECTION | False | AP | 2006-08-28 | CIPROFLOXACIN |
| 13 | ANDA077753_001 | RX | CIPROFLOXACIN (200MG/100ML) | INJECTION | False | AP | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
| 14 | ANDA077753_002 | RX | CIPROFLOXACIN (400MG/200ML) | INJECTION | False | AP | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
| 15 | ANDA077782_001 | discontinued | CIPROFLOXACIN (200MG/20ML) | INJECTION | False | 2006-08-28 | CIPROFLOXACIN | |
| 16 | ANDA077782_002 | discontinued | CIPROFLOXACIN (400MG/40ML) | INJECTION | False | 2006-08-28 | CIPROFLOXACIN | |
| 17 | ANDA077888_001 | discontinued | CIPROFLOXACIN (200MG/100ML) | INJECTION | False | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | |
| 18 | ANDA077888_002 | discontinued | CIPROFLOXACIN (400MG/200ML) | INJECTION | False | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | |
| 19 | ANDA078024_001 | RX | CIPROFLOXACIN (200MG/100ML) | INJECTION | False | AP | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
| 20 | ANDA078024_002 | RX | CIPROFLOXACIN (400MG/200ML) | INJECTION | False | AP | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
| 21 | ANDA078062_001 | RX | CIPROFLOXACIN (200MG/20ML) | INJECTION | False | AP | 2008-04-29 | CIPROFLOXACIN |
| 22 | ANDA078062_002 | RX | CIPROFLOXACIN (400MG/40ML) | INJECTION | False | AP | 2008-04-29 | CIPROFLOXACIN |
| 23 | ANDA078114_001 | discontinued | CIPROFLOXACIN (200MG/100ML) | INJECTION | False | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | |
| 24 | ANDA078114_002 | discontinued | CIPROFLOXACIN (400MG/200ML) | INJECTION | False | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | |
| 25 | ANDA078252_001 | RX | CIPROFLOXACIN (200MG/100ML) | INJECTION | False | AP | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
| 26 | ANDA078252_002 | RX | CIPROFLOXACIN (400MG/200ML) | INJECTION | False | AP | 2008-03-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
| 27 | ANDA078431_001 | RX | CIPROFLOXACIN (400MG/200ML) | INJECTION | False | AP | 2009-11-18 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
| 28 | NDA019847_001 | RX | CIPROFLOXACIN (400MG/40ML) | INJECTION | True | AP | 1990-12-26 | CIPRO |
| 29 | NDA019847_002 | RX | CIPROFLOXACIN (200MG/20ML) | INJECTION | True | AP | 1990-12-26 | CIPRO |
| 30 | NDA019847_003 | discontinued | CIPROFLOXACIN (1200MG/120ML) | INJECTION | False | 1990-12-26 | CIPRO | |
| 31 | NDA019857_001 | RX | CIPROFLOXACIN (200MG/100ML) | INJECTION | True | AP | 1990-12-26 | CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER |
| 32 | NDA019857_002 | RX | CIPROFLOXACIN (400MG/200ML) | INJECTION | True | AP | 1990-12-26 | CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER |
| 33 | NDA019858_001 | discontinued | CIPROFLOXACIN (200MG/100ML) | INJECTION | False | 1990-12-26 | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 19df63de-9f44-40ce-9a4f-0c96345b8a23 (view SPL) | Ciprofloxacin Injection, USP | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2010-12-16 | 1 | 216950422 |
| 2 | 231b60f5-4b72-4f8f-a19e-b7068a601c3a (view SPL) | CIPROFLOXACIN INJECTION, USP For Intravenous Infusion | prescription | Human Prescription | Sandoz Inc | 2015-03-10 | 12 | 007813239, 007813240 | |
| 3 | 457d7810-23f1-4318-9561-2cd58a9cf973 (view SPL) | These highlights do not include all the information needed to use CIPRO IV safely and effectively. See full prescribing information for CIPRO IV.CIPRO IV (ciprofloxacin) injection, for intravenous useInitial U.S. Approval: 1990 | prescription | Human Prescription | Bayer Healthcare Pharmaceuticals Inc. | MANUFACTURE | 2015-03-17 | 12 | 504190759 |
| 4 | 65fff92f-b51b-4f5e-20bd-b651e613578d (view SPL) | These highlights do not include all the information needed to use Ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. Ciprofloxacin Injection, USP in 5% Dextrose for intravenous infusion Initial U.S. Approval: 2006 | prescription | Human Prescription | Hospira, Inc. | 2015-09-29 | 9 | 004094777 | |
| 5 | 7049f870-6741-4a67-8033-398c36126a06 (view SPL) | These highlights do not include all the information needed to use Ciprofloxacin Injection, USP safely and effectively. See full prescribing information for Ciprofloxacin Injection, USP.Ciprofloxacin Injection, USP, for intravenous useInitial U.S. Approval: 1990 | prescription | Human Prescription | Sagent Pharmaceuticals | 2015-05-28 | 12 | 250210114 | |
| 6 | 7217ffdd-bcd2-48b7-a397-da966ea533bd (view SPL) | ciprofloxacin injection, USP (1% w/v) and ciprofloxacin in dextrose (5%) injection, USP(ciprofloxacin)For Intravenous Infusion | prescription | Human Prescription | Pfizer Labs | analysis, manufacture | 2009-09-17 | 2 | 000693241, 000693342, 000694395, 000694396 |
| 7 | 9deb95f4-83a0-4928-a55d-41f7f02bb3f3 (view SPL) | These highlights do not include all the information needed to use Ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin.Ciprofloxacin Injection, USP in 5% Dextrose for intravenous infusion Initial U.S. Approval: 2006 | prescription | Human Prescription | Hospira, Inc. | 2015-10-02 | 3 | 004094777 | |
| 8 | a341d31b-a011-457a-76a1-a96146d2924e (view SPL) | These highlights do not include all the information needed to use Ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. Ciprofloxacin Injection, USP for intravenous infusion Initial U.S. Approval: 2006 | prescription | Human Prescription | Hospira, Inc. | 2015-10-01 | 13 | 004094765, 004094778 | |
| 9 | d4730085-b38e-43ce-bb51-2532da0a3e2b (view SPL) | Ciprofloxacin Injection, USP | prescription | Human Prescription | Rebel Distributors Corp | RELABEL, REPACK | 2011-01-11 | 1 | 216950914 |
| 10 | e82f52f2-ecf8-4c04-a206-f3253b265903 (view SPL) | Ciprofloxacin Injection, USP (1% w/v) and Ciprofloxacin in Dextrose (5%) Injection, USP(ciprofloxacin)For Intravenous Infusion | prescription | Human Prescription | Claris Lifesciences Inc. | 2015-07-01 | 11 | 360000008, 360000009, 360000010, 360000011, 360000029, 360000030 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII