Bacitracin / Hydrocortisone / Neomycin / Polymyxin B Ophthalmic Ointment

Brand(s)
Cortomycin Ointment, Neo-Polycin HC
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2013-11-01)
Oldest Current Product
1981-04-14
License(s)
ANDA
RxNORM
OPHTHALMIC OINTMENT\BACITRACIN:HYDROCORTISONE:NEOMYCIN:POLYMYXIN B
FDAOB
OPHTHALMIC\OINTMENT\BACITRACIN ZINC: HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
OPHTHALMIC\OINTMENT\BACITRACIN: HYDROCORTISONE ACETATE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Active
OPHTHALMIC\OINTMENT\BACITRACIN ZINC: HYDROCORTISONE ACETATE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
OPHTHALMIC\OINTMENT\BACITRACIN ZINC: HYDROCORTISONE: NEOMYCIN SULFATE: POLYMYXIN B SULFATE
SPL Moiety
OPHTHALMIC\OINTMENT\BACITRACIN: HYDROCORTISONE: NEOMYCIN: POLYMYXIN B

product(s) by strength(s)

bacitracin 0.4 unt/mg / hydrocortisone 0.01 mg/mg / neomycin 0.0035 mg/mg / polymyxin b 10 unt/mg ophthalmic ointment

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009042995Cortomycin OintmentANDAMajor1995-10-30BACITRACIN ZINC, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0640687c50e7f2-1208-4f19-9807-4ab0dd314d3b

bacitracin zinc 0.4 unt/mg / hydrocortisone acetate 0.01 mg/mg / neomycin sulfate 0.0035 mg/mg / polymyxin b sulfate 10 unt/mg ophthalmic ointment

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004047195ANDAHenry Schein Inc.2015-05-13BACITRACIN ZINC, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0652133899b358-bf5f-49b5-9183-23c910339f75
2005744144Neo-Polycin HCANDAPaddock Laboratories, Llc2015-01-07BACITRACIN ZINC, HYDROCORTISONE ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA062166c9996e7a-36f0-4e2e-b887-91d1d06b326e
3116951406ANDAButler Animal Health Supply1995-10-30BACITRACIN ZINC, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0640686541631a-6c77-44fc-b6ac-3b91e42e3065
4139850016ANDAMwi1995-10-30BACITRACIN ZINC, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA06406810195234-e8c4-455a-9e27-0333f454ea3f
5139850608ANDAMwi2015-03-23BACITRACIN ZINC, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA065213f914f577-32aa-4b7a-9996-ca24b34f022d
6140490467ANDARxv1995-10-30BACITRACIN ZINC, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA064068361fd3cd-4e84-46e6-a05a-da600a539239
7174780719ANDAAkorn2012-07-25BACITRACIN ZINC, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA065213ce7ded34-66ab-4b6d-a9d7-fcf0c8d86eaa
8242080785ANDABausch & Lomb Incorporated1995-10-30BACITRACIN ZINC, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0640683b00eb5c-dd98-467e-a883-04c37a8ecc42
9481020005Neo-Polycin HCANDAFera Pharmaceuticals2011-07-01BACITRACIN ZINC, HYDROCORTISONE ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0621666ae8f960-512c-47a7-9bc7-0fe87be48519
10573190344ANDAClipper Distributing Company, Llc1995-10-30BACITRACIN ZINC, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENTANDA0640688b45f06d-ad0b-447a-ab1d-14cab8ca4043

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950736ANDARebel Distributors Corp1981-04-14BACITRACIN ZINC, HYDROCORTISONE ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENT001680029ANDA062166bdee074e-e813-4403-897c-1ccb32bd6548
2548686122ANDAPhysicians Total Care, Inc.2010-05-04BACITRACIN ZINC, HYDROCORTISONE ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOPHTHALMICOINTMENT001680029ANDA062166e76c3a5a-d417-473b-ab9a-165d9d9963c6

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060731BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATETrueALTANA INCANDA060731_002
2ANDA062166BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATEPERRIGO CO TENNESSEE INCANDA062166_002
3ANDA062389ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONETruePHARMAFAIR INC1982-07-02ANDA062389_001
4ANDA064068NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEBAUSCH AND LOMB PHARMACEUTICALS INC1995-10-30ANDA064068_001
5ANDA065213NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEAKORN INC2012-07-25ANDA065213_001
6NDA050416CORTISPORINTrueCITRON PHARMA LLCNDA050416_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060731_002discontinuedNEOMYCIN SULFATE (EQ 3.5MG BASE/GM), HYDROCORTISONE ACETATE (1%), BACITRACIN (400 UNITS/GM), POLYMYXIN B SULFATE (10,000 UNITS/GM)OPHTHALMICOINTMENTFalseBACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
2ANDA062166_002RXNEOMYCIN SULFATE (EQ 3.5MG BASE/GM), HYDROCORTISONE ACETATE (1%), BACITRACIN (400 UNITS/GM), POLYMYXIN B SULFATE (10,000 UNITS/GM)OPHTHALMICOINTMENTTrueBACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
3ANDA062389_001discontinuedHYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/GM), BACITRACIN ZINC (400 UNITS/GM), POLYMYXIN B SULFATE (10,000 UNITS/GM)OPHTHALMICOINTMENTFalse1982-07-02ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE
4ANDA064068_001RXHYDROCORTISONE (1%), POLYMYXIN B SULFATE (10,000 UNITS/GM), NEOMYCIN SULFATE (EQ 3.5MG BASE/GM), BACITRACIN ZINC (400 UNITS/GM)OPHTHALMICOINTMENTTrueAT1995-10-30NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
5ANDA065213_001RXPOLYMYXIN B SULFATE (10,000 UNITS/GM), NEOMYCIN SULFATE (EQ 3.5MG BASE/GM), HYDROCORTISONE (1%), BACITRACIN ZINC (400 UNITS/GM)OPHTHALMICOINTMENTFalseAT2012-07-25NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
6NDA050416_002discontinuedBACITRACIN ZINC (400 UNITS/GM), HYDROCORTISONE (1%), NEOMYCIN SULFATE (EQ 3.5MG BASE/GM), POLYMYXIN B SULFATE (10,000 UNITS/GM)OPHTHALMICOINTMENTFalseCORTISPORIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
110195234-e8c4-455a-9e27-0333f454ea3f (view SPL)Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP(Sterile)prescriptionHuman PrescriptionMwiMANUFACTURE2010-11-041139850016
2361fd3cd-4e84-46e6-a05a-da600a539239 (view SPL)Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP(Sterile)prescriptionHuman PrescriptionRxvMANUFACTURE2010-11-041140490467
33899b358-bf5f-49b5-9183-23c910339f75 (view SPL)Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortesone Ophthalmic Ointment, USPprescriptionHuman PrescriptionHenry Schein Inc.2015-05-131004047195
43b00eb5c-dd98-467e-a883-04c37a8ecc42 (view SPL)Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2013-11-015242080785
56541631a-6c77-44fc-b6ac-3b91e42e3065 (view SPL)Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP(Sterile)prescriptionHuman PrescriptionButler Animal Health SupplyMANUFACTURE2010-11-041116951406
66ae8f960-512c-47a7-9bc7-0fe87be48519 (view SPL)NEO-POLYCIN HCprescriptionHuman PrescriptionFera Pharmaceuticals2011-07-121481020005
77c50e7f2-1208-4f19-9807-4ab0dd314d3b (view SPL)Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP(Sterile)prescriptionHuman PrescriptionMajorMANUFACTURE2010-11-041009042995
88b45f06d-ad0b-447a-ab1d-14cab8ca4043 (view SPL)Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP(Sterile)prescriptionHuman PrescriptionClipper Distributing Company, LlcMANUFACTURE2010-11-041573190344
9bdee074e-e813-4403-897c-1ccb32bd6548 (view SPL)NEOMYCIN and POLYMYXIN B SULFATES and BACITRACIN ZINC with HYDROCORTISONE ACETATE OPHTHALMIC OINTMENTprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-031216950736
10c9996e7a-36f0-4e2e-b887-91d1d06b326e (view SPL)Neo-Polycin HC neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone acetate Ophthalmic Ointment USPSTERILE Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2015-01-081005744144
11ce7ded34-66ab-4b6d-a9d7-fcf0c8d86eaa (view SPL)Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment, USPprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2012-07-271174780719
12e76c3a5a-d417-473b-ab9a-165d9d9963c6 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-05-112548686122
13f914f577-32aa-4b7a-9996-ca24b34f022d (view SPL)apexaNeomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneprescriptionHuman PrescriptionMwiANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-03-231139850608

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