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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000090005 | Solu-Cortef | NDA | Pharmacia And Upjohn Company | 1955-04-27 | HYDROCORTISONE SODIUM SUCCINATE | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | NDA009866 | 65eefd58-b166-4d71-ade6-45c8fdf86922 |
| 2 | 000090013 | Solu-Cortef | NDA | Pharmacia And Upjohn Company | 1955-04-27 | HYDROCORTISONE SODIUM SUCCINATE | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | NDA009866 | 65eefd58-b166-4d71-ade6-45c8fdf86922 |
hydrocortisone 50 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000090011 | Solu-Cortef | NDA | Pharmacia And Upjohn Company | 1955-04-27 | HYDROCORTISONE SODIUM SUCCINATE | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | NDA009866 | 65eefd58-b166-4d71-ade6-45c8fdf86922 |
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 004094856 | A-Hydrocort | ANDA | Hospira, Inc. | 2011-05-12 | HYDROCORTISONE SODIUM SUCCINATE | INTRAMUSCULAR | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA040666 | 6d9bf1b0-599e-41da-7092-32f571ed79b1 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 551543925 | Solu-Cortef | NDA | Cardinal Health | 1955-04-27 | HYDROCORTISONE SODIUM SUCCINATE | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | 000090900 | NDA009866 | b2b4c961-363d-49fe-b354-d59b39fd517a |
| 2 | 551543942 | Solu-Cortef | NDA | Cardinal Health | 1955-04-27 | HYDROCORTISONE SODIUM SUCCINATE | INTRAMUSCULAR | INJECTION, POWDER, FOR SOLUTION | 000090011 | NDA009866 | f5bb0854-a477-4e59-914b-eeeaef92a596 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA040666 | A-HYDROCORT | HOSPIRA INC | 2006-04-06 | ANDA040666_001 | |
| 2 | ANDA084737 | HYDROCORTISONE SODIUM SUCCINATE | True | WATSON LABORATORIES INC | ANDA084737_001, ANDA084737_002 | |
| 3 | ANDA084738 | HYDROCORTISONE SODIUM SUCCINATE | True | WATSON LABORATORIES INC | ANDA084738_001 | |
| 4 | ANDA084747 | HYDROCORTISONE SODIUM SUCCINATE | True | WATSON LABORATORIES INC | ANDA084747_001 | |
| 5 | ANDA084748 | HYDROCORTISONE SODIUM SUCCINATE | True | WATSON LABORATORIES INC | ANDA084748_001 | |
| 6 | ANDA085928 | A-HYDROCORT | True | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | ANDA085928_001 | |
| 7 | ANDA085929 | A-HYDROCORT | True | HOSPIRA INC | ANDA085929_001 | |
| 8 | ANDA085930 | A-HYDROCORT | True | HOSPIRA WORLDWIDE, INC | ANDA085930_001 | |
| 9 | ANDA085931 | A-HYDROCORT | True | HOSPIRA WORLDWIDE, INC | ANDA085931_001 | |
| 10 | ANDA085932 | A-HYDROCORT | True | HOSPIRA WORLDWIDE, INC | ANDA085932_001 | |
| 11 | ANDA086619 | HYDROCORTISONE SODIUM SUCCINATE | True | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | ANDA086619_001 | |
| 12 | ANDA087532 | HYDROCORTISONE SODIUM SUCCINATE | True | INTERNATIONAL MEDICATION SYSTEMS LTD | 1982-03-19 | ANDA087532_001 |
| 13 | ANDA087567 | HYDROCORTISONE SODIUM SUCCINATE | True | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | ANDA087567_001 | |
| 14 | ANDA087568 | HYDROCORTISONE SODIUM SUCCINATE | True | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | ANDA087568_001 | |
| 15 | ANDA087569 | HYDROCORTISONE SODIUM SUCCINATE | True | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | ANDA087569_001 | |
| 16 | ANDA088667 | HYDROCORTISONE SODIUM SUCCINATE | True | ABRAXIS PHARMACEUTICAL PRODUCTS | 1984-06-08 | ANDA088667_001 |
| 17 | ANDA088668 | HYDROCORTISONE SODIUM SUCCINATE | True | ABRAXIS PHARMACEUTICAL PRODUCTS | 1984-06-08 | ANDA088668_001 |
| 18 | ANDA088669 | HYDROCORTISONE SODIUM SUCCINATE | True | ABRAXIS PHARMACEUTICAL PRODUCTS | 1984-06-08 | ANDA088669_001 |
| 19 | ANDA088670 | HYDROCORTISONE SODIUM SUCCINATE | True | ABRAXIS PHARMACEUTICAL PRODUCTS | 1984-06-08 | ANDA088670_001 |
| 20 | ANDA088712 | HYDROCORTISONE SODIUM SUCCINATE | True | ABRAXIS PHARMACEUTICAL PRODUCTS | 1984-06-08 | ANDA088712_001 |
| 21 | ANDA089577 | A-HYDROCORT | True | ABBOTT LABORATORIES HOSP PRODUCTS DIV | 1989-04-11 | ANDA089577_001 |
| 22 | ANDA089578 | A-HYDROCORT | True | ABBOTT LABORATORIES HOSP PRODUCTS DIV | 1989-04-11 | ANDA089578_001 |
| 23 | ANDA089579 | A-HYDROCORT | True | ABBOTT LABORATORIES HOSP PRODUCTS DIV | 1989-04-11 | ANDA089579_001 |
| 24 | ANDA089580 | A-HYDROCORT | True | ABBOTT LABORATORIES HOSP PRODUCTS DIV | 1989-04-11 | ANDA089580_001 |
| 25 | NDA009866 | SOLU-CORTEF | PHARMACIA AND UPJOHN CO | NDA009866_001, NDA009866_002, NDA009866_003, NDA009866_004 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040666_001 | RX | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | False | AP | 2006-04-06 | A-HYDROCORT |
| 2 | ANDA084737_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL) | INJECTION | False | HYDROCORTISONE SODIUM SUCCINATE | ||
| 3 | ANDA084737_002 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | False | HYDROCORTISONE SODIUM SUCCINATE | ||
| 4 | ANDA084738_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | False | HYDROCORTISONE SODIUM SUCCINATE | ||
| 5 | ANDA084747_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL) | INJECTION | False | HYDROCORTISONE SODIUM SUCCINATE | ||
| 6 | ANDA084748_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL) | INJECTION | False | HYDROCORTISONE SODIUM SUCCINATE | ||
| 7 | ANDA085928_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | False | A-HYDROCORT | ||
| 8 | ANDA085929_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | False | A-HYDROCORT | ||
| 9 | ANDA085930_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL) | INJECTION | False | A-HYDROCORT | ||
| 10 | ANDA085931_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL) | INJECTION | False | A-HYDROCORT | ||
| 11 | ANDA085932_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL) | INJECTION | False | A-HYDROCORT | ||
| 12 | ANDA086619_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | False | HYDROCORTISONE SODIUM SUCCINATE | ||
| 13 | ANDA087532_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | False | 1982-03-19 | HYDROCORTISONE SODIUM SUCCINATE | |
| 14 | ANDA087567_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL) | INJECTION | False | HYDROCORTISONE SODIUM SUCCINATE | ||
| 15 | ANDA087568_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL) | INJECTION | False | HYDROCORTISONE SODIUM SUCCINATE | ||
| 16 | ANDA087569_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL) | INJECTION | False | HYDROCORTISONE SODIUM SUCCINATE | ||
| 17 | ANDA088667_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | False | 1984-06-08 | HYDROCORTISONE SODIUM SUCCINATE | |
| 18 | ANDA088668_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL) | INJECTION | False | 1984-06-08 | HYDROCORTISONE SODIUM SUCCINATE | |
| 19 | ANDA088669_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL) | INJECTION | False | 1984-06-08 | HYDROCORTISONE SODIUM SUCCINATE | |
| 20 | ANDA088670_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL) | INJECTION | False | 1984-06-08 | HYDROCORTISONE SODIUM SUCCINATE | |
| 21 | ANDA088712_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | False | 1984-06-08 | HYDROCORTISONE SODIUM SUCCINATE | |
| 22 | ANDA089577_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | False | 1989-04-11 | A-HYDROCORT | |
| 23 | ANDA089578_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL) | INJECTION | False | 1989-04-11 | A-HYDROCORT | |
| 24 | ANDA089579_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL) | INJECTION | False | 1989-04-11 | A-HYDROCORT | |
| 25 | ANDA089580_001 | discontinued | HYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL) | INJECTION | False | 1989-04-11 | A-HYDROCORT | |
| 26 | NDA009866_001 | RX | HYDROCORTISONE SODIUM SUCCINATE (EQ 100MG BASE/VIAL) | INJECTION | True | AP | SOLU-CORTEF | |
| 27 | NDA009866_002 | RX | HYDROCORTISONE SODIUM SUCCINATE (EQ 250MG BASE/VIAL) | INJECTION | True | AP | SOLU-CORTEF | |
| 28 | NDA009866_003 | RX | HYDROCORTISONE SODIUM SUCCINATE (EQ 500MG BASE/VIAL) | INJECTION | True | AP | SOLU-CORTEF | |
| 29 | NDA009866_004 | RX | HYDROCORTISONE SODIUM SUCCINATE (EQ 1GM BASE/VIAL) | INJECTION | True | AP | SOLU-CORTEF |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 65eefd58-b166-4d71-ade6-45c8fdf86922 (view SPL) | SOLU-CORTEF (hydrocortisone sodium succinate for injection, USP) | prescription | Human Prescription | Pharmacia And Upjohn Company | ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK | 2014-08-14 | 15 | 000090005, 000090011, 000090013, 000090016, 000090825 |
| 2 | 6d9bf1b0-599e-41da-7092-32f571ed79b1 (view SPL) | A-HYDROCORT | prescription | Human Prescription | Hospira, Inc. | 2011-05-12 | 10 | 004094856 | |
| 3 | b2b4c961-363d-49fe-b354-d59b39fd517a (view SPL) | SOLU-CORTEF (hydrocortisone sodium succinate for injection, USP) | prescription | Human Prescription | Cardinal Health | REPACK | 2012-05-16 | 1 | 551543925 |
| 4 | f5bb0854-a477-4e59-914b-eeeaef92a596 (view SPL) | SOLU-CORTEF (hydrocortisone sodium succinate for injection, USP) | prescription | Human Prescription | Cardinal Health | REPACK | 2015-01-07 | 6 | 551543942 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII