Hydrocortisone Injectable Solution

Brand(s)
A-Hydrocort, Solu-Cortef
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-08-14)
Oldest Current Product
1955-04-27
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\HYDROCORTISONE
FDAOB
INJECTION\INJECTION\HYDROCORTISONE SODIUM SUCCINATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\HYDROCORTISONE SODIUM SUCCINATE
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HYDROCORTISONE SODIUM SUCCINATE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, FOR SOLUTION\HYDROCORTISONE
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HYDROCORTISONE

product(s) by strength(s)

hydrocortisone 125 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090005Solu-CortefNDAPharmacia And Upjohn Company1955-04-27HYDROCORTISONE SODIUM SUCCINATEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA00986665eefd58-b166-4d71-ade6-45c8fdf86922
2000090013Solu-CortefNDAPharmacia And Upjohn Company1955-04-27HYDROCORTISONE SODIUM SUCCINATEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA00986665eefd58-b166-4d71-ade6-45c8fdf86922

hydrocortisone 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090011Solu-CortefNDAPharmacia And Upjohn Company1955-04-27HYDROCORTISONE SODIUM SUCCINATEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTIONNDA00986665eefd58-b166-4d71-ade6-45c8fdf86922

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004094856A-HydrocortANDAHospira, Inc.2011-05-12HYDROCORTISONE SODIUM SUCCINATEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0406666d9bf1b0-599e-41da-7092-32f571ed79b1

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551543925Solu-CortefNDACardinal Health1955-04-27HYDROCORTISONE SODIUM SUCCINATEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTION000090900NDA009866b2b4c961-363d-49fe-b354-d59b39fd517a
2551543942Solu-CortefNDACardinal Health1955-04-27HYDROCORTISONE SODIUM SUCCINATEINTRAMUSCULARINJECTION, POWDER, FOR SOLUTION000090011NDA009866f5bb0854-a477-4e59-914b-eeeaef92a596

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040666A-HYDROCORTHOSPIRA INC2006-04-06ANDA040666_001
2ANDA084737HYDROCORTISONE SODIUM SUCCINATETrueWATSON LABORATORIES INCANDA084737_001, ANDA084737_002
3ANDA084738HYDROCORTISONE SODIUM SUCCINATETrueWATSON LABORATORIES INCANDA084738_001
4ANDA084747HYDROCORTISONE SODIUM SUCCINATETrueWATSON LABORATORIES INCANDA084747_001
5ANDA084748HYDROCORTISONE SODIUM SUCCINATETrueWATSON LABORATORIES INCANDA084748_001
6ANDA085928A-HYDROCORTTrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA085928_001
7ANDA085929A-HYDROCORTTrueHOSPIRA INCANDA085929_001
8ANDA085930A-HYDROCORTTrueHOSPIRA WORLDWIDE, INCANDA085930_001
9ANDA085931A-HYDROCORTTrueHOSPIRA WORLDWIDE, INCANDA085931_001
10ANDA085932A-HYDROCORTTrueHOSPIRA WORLDWIDE, INCANDA085932_001
11ANDA086619HYDROCORTISONE SODIUM SUCCINATETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CAREANDA086619_001
12ANDA087532HYDROCORTISONE SODIUM SUCCINATETrueINTERNATIONAL MEDICATION SYSTEMS LTD1982-03-19ANDA087532_001
13ANDA087567HYDROCORTISONE SODIUM SUCCINATETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CAREANDA087567_001
14ANDA087568HYDROCORTISONE SODIUM SUCCINATETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CAREANDA087568_001
15ANDA087569HYDROCORTISONE SODIUM SUCCINATETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CAREANDA087569_001
16ANDA088667HYDROCORTISONE SODIUM SUCCINATETrueABRAXIS PHARMACEUTICAL PRODUCTS1984-06-08ANDA088667_001
17ANDA088668HYDROCORTISONE SODIUM SUCCINATETrueABRAXIS PHARMACEUTICAL PRODUCTS1984-06-08ANDA088668_001
18ANDA088669HYDROCORTISONE SODIUM SUCCINATETrueABRAXIS PHARMACEUTICAL PRODUCTS1984-06-08ANDA088669_001
19ANDA088670HYDROCORTISONE SODIUM SUCCINATETrueABRAXIS PHARMACEUTICAL PRODUCTS1984-06-08ANDA088670_001
20ANDA088712HYDROCORTISONE SODIUM SUCCINATETrueABRAXIS PHARMACEUTICAL PRODUCTS1984-06-08ANDA088712_001
21ANDA089577A-HYDROCORTTrueABBOTT LABORATORIES HOSP PRODUCTS DIV1989-04-11ANDA089577_001
22ANDA089578A-HYDROCORTTrueABBOTT LABORATORIES HOSP PRODUCTS DIV1989-04-11ANDA089578_001
23ANDA089579A-HYDROCORTTrueABBOTT LABORATORIES HOSP PRODUCTS DIV1989-04-11ANDA089579_001
24ANDA089580A-HYDROCORTTrueABBOTT LABORATORIES HOSP PRODUCTS DIV1989-04-11ANDA089580_001
25NDA009866SOLU-CORTEFPHARMACIA AND UPJOHN CONDA009866_001, NDA009866_002, NDA009866_003, NDA009866_004

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040666_001RXHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONFalseAP2006-04-06A-HYDROCORT
2ANDA084737_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL)INJECTIONFalseHYDROCORTISONE SODIUM SUCCINATE
3ANDA084737_002discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONFalseHYDROCORTISONE SODIUM SUCCINATE
4ANDA084738_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONFalseHYDROCORTISONE SODIUM SUCCINATE
5ANDA084747_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL)INJECTIONFalseHYDROCORTISONE SODIUM SUCCINATE
6ANDA084748_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONFalseHYDROCORTISONE SODIUM SUCCINATE
7ANDA085928_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONFalseA-HYDROCORT
8ANDA085929_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONFalseA-HYDROCORT
9ANDA085930_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL)INJECTIONFalseA-HYDROCORT
10ANDA085931_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL)INJECTIONFalseA-HYDROCORT
11ANDA085932_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONFalseA-HYDROCORT
12ANDA086619_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONFalseHYDROCORTISONE SODIUM SUCCINATE
13ANDA087532_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONFalse1982-03-19HYDROCORTISONE SODIUM SUCCINATE
14ANDA087567_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL)INJECTIONFalseHYDROCORTISONE SODIUM SUCCINATE
15ANDA087568_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL)INJECTIONFalseHYDROCORTISONE SODIUM SUCCINATE
16ANDA087569_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONFalseHYDROCORTISONE SODIUM SUCCINATE
17ANDA088667_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONFalse1984-06-08HYDROCORTISONE SODIUM SUCCINATE
18ANDA088668_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL)INJECTIONFalse1984-06-08HYDROCORTISONE SODIUM SUCCINATE
19ANDA088669_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL)INJECTIONFalse1984-06-08HYDROCORTISONE SODIUM SUCCINATE
20ANDA088670_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONFalse1984-06-08HYDROCORTISONE SODIUM SUCCINATE
21ANDA088712_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONFalse1984-06-08HYDROCORTISONE SODIUM SUCCINATE
22ANDA089577_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONFalse1989-04-11A-HYDROCORT
23ANDA089578_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL)INJECTIONFalse1989-04-11A-HYDROCORT
24ANDA089579_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL)INJECTIONFalse1989-04-11A-HYDROCORT
25ANDA089580_001discontinuedHYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONFalse1989-04-11A-HYDROCORT
26NDA009866_001RXHYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL)INJECTIONTrueAPSOLU-CORTEF
27NDA009866_002RXHYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL)INJECTIONTrueAPSOLU-CORTEF
28NDA009866_003RXHYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL)INJECTIONTrueAPSOLU-CORTEF
29NDA009866_004RXHYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL)INJECTIONTrueAPSOLU-CORTEF

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
165eefd58-b166-4d71-ade6-45c8fdf86922 (view SPL)SOLU-CORTEF (hydrocortisone sodium succinate for injection, USP)prescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-08-1415000090005, 000090011, 000090013, 000090016, 000090825
26d9bf1b0-599e-41da-7092-32f571ed79b1 (view SPL)A-HYDROCORTprescriptionHuman PrescriptionHospira, Inc.2011-05-1210004094856
3b2b4c961-363d-49fe-b354-d59b39fd517a (view SPL)SOLU-CORTEF (hydrocortisone sodium succinate for injection, USP)prescriptionHuman PrescriptionCardinal HealthREPACK2012-05-161551543925
4f5bb0854-a477-4e59-914b-eeeaef92a596 (view SPL)SOLU-CORTEF (hydrocortisone sodium succinate for injection, USP)prescriptionHuman PrescriptionCardinal HealthREPACK2015-01-076551543942

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