Butorphanol Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2014-01-27)
Oldest Current Product
1997-01-23
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\BUTORPHANOL
FDAOB
INJECTION\INJECTION\BUTORPHANOL TARTRATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\BUTORPHANOL TARTRATE
INTRAMUSCULAR\INJECTION\BUTORPHANOL TARTRATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\BUTORPHANOL
INTRAMUSCULAR\INJECTION\BUTORPHANOL

product(s) by strength(s)

butorphanol tartrate 1 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439864ANDAWest-Ward Pharmaceutical Corp2009-05-01BUTORPHANOL TARTRATEINTRAMUSCULARINJECTION, SOLUTIONANDA078400bded5531-8847-4576-9a29-3e44f979d2e0
2004091623ANDAHospira, Inc.1997-01-23BUTORPHANOL TARTRATEINTRAMUSCULARINJECTION, SOLUTIONANDA0746269822ca3f-aee2-46e5-8a96-495400e65d10

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551540367ANDACardinal Health1998-10-15BUTORPHANOL TARTRATEINTRAMUSCULARINJECTION553900183ANDA0750450ad9ad5f-66ad-451c-bc40-9f7c40d4b70c

butorphanol tartrate 2 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439867ANDAWest-Ward Pharmaceutical Corp2009-05-01BUTORPHANOL TARTRATEINTRAMUSCULARINJECTION, SOLUTIONANDA078400bded5531-8847-4576-9a29-3e44f979d2e0
2004091626ANDAHospira, Inc.1997-01-23BUTORPHANOL TARTRATEINTRAMUSCULARINJECTION, SOLUTIONANDA0746269822ca3f-aee2-46e5-8a96-495400e65d10

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840626ANDAGeneral Injecatables & Vaccines, Inc2013-08-14BUTORPHANOL TARTRATEINTRAMUSCULARINJECTION, SOLUTION004091626ANDA0746260f24ca6f-8809-483f-8349-46f5f88b68f7
2551540366ANDACardinal Health1998-10-15BUTORPHANOL TARTRATEINTRAMUSCULARINJECTION553900184ANDA0750450ad9ad5f-66ad-451c-bc40-9f7c40d4b70c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074620BUTORPHANOL TARTRATE PRESERVATIVE FREETrueHOSPIRA INC1997-01-22ANDA074620_001, ANDA074620_002
2ANDA074626BUTORPHANOL TARTRATE PRESERVATIVE FREEHOSPIRA INC1997-01-23ANDA074626_001, ANDA074626_002
3ANDA075045BUTORPHANOL TARTRATE PRESERVATIVE FREEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1998-08-12ANDA075045_001, ANDA075045_002
4ANDA075046BUTORPHANOL TARTRATEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1998-08-12ANDA075046_001
5ANDA075170BUTORPHANOL TARTRATE PRESERVATIVE FREETrueHOSPIRA WORLDWIDE, INC1998-09-28ANDA075170_001, ANDA075170_002
6ANDA075342BUTORPHANOL TARTRATETrueHOSPIRA INC1999-11-04ANDA075342_001, ANDA075342_002
7ANDA075559BUTORPHANOL TARTRATETrueHOSPIRA INC2000-03-20ANDA075559_001, ANDA075559_002
8ANDA075695BUTORPHANOL TARTRATE PRESERVATIVE FREETrueAPOTEX INC2001-10-23ANDA075695_001, ANDA075695_002
9ANDA075697BUTORPHANOL TARTRATETrueAPOTEX INC2001-10-23ANDA075697_001
10ANDA078247BUTORPHANOL TARTRATETrueHIKMA FARMACEUTICA SA2009-04-29ANDA078247_001
11ANDA078400BUTORPHANOL TARTRATEHIKMA FARMACEUTICA (PORTUGAL) SA2009-05-01ANDA078400_001, ANDA078400_002
12NDA017857STADOLTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBNDA017857_001, NDA017857_002, NDA017857_004

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074620_001discontinuedBUTORPHANOL TARTRATE (1MG/ML)INJECTIONFalse1997-01-22BUTORPHANOL TARTRATE PRESERVATIVE FREE
2ANDA074620_002discontinuedBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalse1997-01-22BUTORPHANOL TARTRATE PRESERVATIVE FREE
3ANDA074626_001RXBUTORPHANOL TARTRATE (1MG/ML)INJECTIONFalseAP1997-01-23BUTORPHANOL TARTRATE PRESERVATIVE FREE
4ANDA074626_002RXBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalseAP1997-01-23BUTORPHANOL TARTRATE PRESERVATIVE FREE
5ANDA075045_001RXBUTORPHANOL TARTRATE (1MG/ML)INJECTIONFalseAP1998-08-12BUTORPHANOL TARTRATE PRESERVATIVE FREE
6ANDA075045_002RXBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalseAP1998-08-12BUTORPHANOL TARTRATE PRESERVATIVE FREE
7ANDA075046_001RXBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalseAP1998-08-12BUTORPHANOL TARTRATE
8ANDA075170_001discontinuedBUTORPHANOL TARTRATE (1MG/ML)INJECTIONFalse1998-09-28BUTORPHANOL TARTRATE PRESERVATIVE FREE
9ANDA075170_002discontinuedBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalse1998-09-28BUTORPHANOL TARTRATE PRESERVATIVE FREE
10ANDA075342_001discontinuedBUTORPHANOL TARTRATE (1MG/ML)INJECTIONFalse1999-11-04BUTORPHANOL TARTRATE
11ANDA075342_002discontinuedBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalse1999-11-04BUTORPHANOL TARTRATE
12ANDA075559_001discontinuedBUTORPHANOL TARTRATE (1MG/ML)INJECTIONFalse2000-03-20BUTORPHANOL TARTRATE
13ANDA075559_002discontinuedBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalse2000-03-20BUTORPHANOL TARTRATE
14ANDA075695_001discontinuedBUTORPHANOL TARTRATE (1MG/ML)INJECTIONFalse2001-10-23BUTORPHANOL TARTRATE PRESERVATIVE FREE
15ANDA075695_002discontinuedBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalse2001-10-23BUTORPHANOL TARTRATE PRESERVATIVE FREE
16ANDA075697_001discontinuedBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalse2001-10-23BUTORPHANOL TARTRATE
17ANDA078247_001discontinuedBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalse2009-04-29BUTORPHANOL TARTRATE
18ANDA078400_001RXBUTORPHANOL TARTRATE (1MG/ML)INJECTIONFalseAP2009-05-01BUTORPHANOL TARTRATE
19ANDA078400_002RXBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalseAP2009-05-01BUTORPHANOL TARTRATE
20NDA017857_001discontinuedBUTORPHANOL TARTRATE (1MG/ML)INJECTIONFalseSTADOL
21NDA017857_002discontinuedBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalseSTADOL
22NDA017857_004discontinuedBUTORPHANOL TARTRATE (2MG/ML)INJECTIONFalseSTADOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10ad9ad5f-66ad-451c-bc40-9f7c40d4b70c (view SPL)BUTORPHANOL TARTRATE INJECTION USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-05-082551540366, 551540367
20f24ca6f-8809-483f-8349-46f5f88b68f7 (view SPL)Butorphanol Tartrate Injection, USP CIVRx onlyProtect from lightGlass Fliptop VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-08-141525840626
39822ca3f-aee2-46e5-8a96-495400e65d10 (view SPL)BUTORPHANOLTARTRATEprescriptionHuman PrescriptionHospira, Inc.2014-01-2711004091623, 004091626
4bded5531-8847-4576-9a29-3e44f979d2e0 (view SPL)Butorphanol Tartrate Injection, USP Rx Only CIVprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2010-03-111001439864, 001439867

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