Nalbuphine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-07-15)
Oldest Current Product
1989-02-03
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\NALBUPHINE
FDAOB
INJECTION\INJECTION\NALBUPHINE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\NALBUPHINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\NALBUPHINE

product(s) by strength(s)

nalbuphine hydrochloride 10 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091463ANDAHospira, Inc.1989-02-03, 2008-06-27NALBUPHINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0709146025e8d4-5083-4c3a-58a0-050e7b0b6150, a99fe500-f52b-483c-807c-178f1a78a02b
2004091464ANDAHospira, Inc.1989-02-03NALBUPHINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0709156025e8d4-5083-4c3a-58a0-050e7b0b6150

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840463ANDAGeneral Injecatables & Vaccines, Inc2010-03-01NALBUPHINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091463ANDA07091408290748-39dc-4f89-b582-b7eb8b482a2e
2551542399ANDACardinal Health1989-02-03NALBUPHINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091463ANDA07091487d32eb5-6806-4aa4-8976-e3ba0fe871df
3551543198ANDACardinal Health1989-02-03NALBUPHINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091463ANDA0709149ad5e836-33bf-49c9-a530-296cff30d1c7

nalbuphine hydrochloride 20 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091465ANDAHospira, Inc.1989-02-03, 2008-06-27NALBUPHINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0709166025e8d4-5083-4c3a-58a0-050e7b0b6150, a99fe500-f52b-483c-807c-178f1a78a02b
2004091467ANDAHospira, Inc.1989-02-03NALBUPHINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0709186025e8d4-5083-4c3a-58a0-050e7b0b6150

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1637390466ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2010-05-03NALBUPHINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION004091465ANDA070916ee8fe2ea-a6c7-485e-bea9-1b94ff66b05c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070751NALBUPHINETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-07-02ANDA070751_001
2ANDA070752NALBUPHINETrueABRAXIS PHARMACEUTICAL PRODUCTS1986-09-24ANDA070752_001
3ANDA070914NALBUPHINE HYDROCHLORIDEHOSPIRA INC1989-02-03ANDA070914_001
4ANDA070915NALBUPHINE HYDROCHLORIDEHOSPIRA INC1989-02-03ANDA070915_001
5ANDA070916NALBUPHINE HYDROCHLORIDEHOSPIRA INC1989-02-03ANDA070916_001
6ANDA070917NALBUPHINE HYDROCHLORIDETrueABBOTT LABORATORIES HOSP PRODUCTS DIV1989-02-03ANDA070917_001
7ANDA070918NALBUPHINE HYDROCHLORIDEHOSPIRA INC1989-02-03ANDA070918_001
8ANDA072070NALBUPHINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-10ANDA072070_001
9ANDA072071NALBUPHINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-10ANDA072071_001
10ANDA072072NALBUPHINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-10ANDA072072_001
11ANDA072073NALBUPHINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-10ANDA072073_001
12ANDA072074NALBUPHINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-10ANDA072074_001
13ANDA072075NALBUPHINE HYDROCHLORIDETrueIGI LABORATORIES INC1989-04-10ANDA072075_001
14ANDA074471NALBUPHINE HYDROCHLORIDETrueBARR LABORATORIES INC1998-03-19ANDA074471_001, ANDA074471_002
15NDA018024NUBAINTrueENDO PHARMACEUTICALS INCNDA018024_001, NDA018024_002
16NDA020200NALBUPHINE HYDROCHLORIDETrueABBVIE INC1993-03-12NDA020200_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070751_001discontinuedNALBUPHINE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1986-07-02NALBUPHINE
2ANDA070752_001discontinuedNALBUPHINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse1986-09-24NALBUPHINE
3ANDA070914_001RXNALBUPHINE HYDROCHLORIDE (10MG/ML)INJECTIONTrueAP1989-02-03NALBUPHINE HYDROCHLORIDE
4ANDA070915_001RXNALBUPHINE HYDROCHLORIDE (10MG/ML)INJECTIONTrueAP1989-02-03NALBUPHINE HYDROCHLORIDE
5ANDA070916_001RXNALBUPHINE HYDROCHLORIDE (20MG/ML)INJECTIONTrueAP1989-02-03NALBUPHINE HYDROCHLORIDE
6ANDA070917_001discontinuedNALBUPHINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse1989-02-03NALBUPHINE HYDROCHLORIDE
7ANDA070918_001RXNALBUPHINE HYDROCHLORIDE (20MG/ML)INJECTIONTrueAP1989-02-03NALBUPHINE HYDROCHLORIDE
8ANDA072070_001discontinuedNALBUPHINE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1989-04-10NALBUPHINE HYDROCHLORIDE
9ANDA072071_001discontinuedNALBUPHINE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1989-04-10NALBUPHINE HYDROCHLORIDE
10ANDA072072_001discontinuedNALBUPHINE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1989-04-10NALBUPHINE HYDROCHLORIDE
11ANDA072073_001discontinuedNALBUPHINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse1989-04-10NALBUPHINE HYDROCHLORIDE
12ANDA072074_001discontinuedNALBUPHINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse1989-04-10NALBUPHINE HYDROCHLORIDE
13ANDA072075_001discontinuedNALBUPHINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse1989-04-10NALBUPHINE HYDROCHLORIDE
14ANDA074471_001discontinuedNALBUPHINE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1998-03-19NALBUPHINE HYDROCHLORIDE
15ANDA074471_002discontinuedNALBUPHINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse1998-03-19NALBUPHINE HYDROCHLORIDE
16NDA018024_001discontinuedNALBUPHINE HYDROCHLORIDE (10MG/ML)INJECTIONFalseNUBAIN
17NDA018024_002discontinuedNALBUPHINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse1982-05-27NUBAIN
18NDA020200_001discontinuedNALBUPHINE HYDROCHLORIDE (1.5MG/ML)INJECTIONFalse1993-03-12NALBUPHINE HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
108290748-39dc-4f89-b582-b7eb8b482a2e (view SPL)Nalbuphine Hydrochloride 10 mg Injection, USP 1 mL Single Dose AmpuleprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-252525840463
26025e8d4-5083-4c3a-58a0-050e7b0b6150 (view SPL)NALBUPHINE HYDROCHLORIDEprescriptionHuman PrescriptionHospira, Inc.2015-07-0712004091463, 004091464, 004091465, 004091467
387d32eb5-6806-4aa4-8976-e3ba0fe871df (view SPL)NALBUPHINE HYDROCHLORIDE InjectionprescriptionHuman PrescriptionCardinal HealthREPACK2012-05-042551542399
49ad5e836-33bf-49c9-a530-296cff30d1c7 (view SPL)NALBUPHINE HYDROCHLORIDE InjectionprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-151551543198
5a99fe500-f52b-483c-807c-178f1a78a02b (view SPL)NALBUPHINE HYDROCHLORIDEprescriptionHuman PrescriptionHospira, Inc.2015-07-151004091463, 004091465
6ee8fe2ea-a6c7-485e-bea9-1b94ff66b05c (view SPL)Nalbuphine HCl Injection1 mL (20 mg)AmpulProtect from light.prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationMANUFACTURE, REPACK2010-05-031637390466

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