Application 009866
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL | Yes | Yes |
| 002 | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 250MG BASE/VIAL | Yes | Yes |
| 003 | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Yes | Yes |
| 004 | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N009866-001 | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N009866-002 | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | ||
| N009866-003 | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | ||
| N009866-004 | SOLU-CORTEF | HYDROCORTISONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N009866-001 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009866-001 | SOLU-CORTEF | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009866-002 | SOLU-CORTEF | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009866-003 | SOLU-CORTEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009866-004 | SOLU-CORTEF | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009866-001 | SOLU-CORTEF | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009866-002 | SOLU-CORTEF | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009866-003 | SOLU-CORTEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009866-004 | SOLU-CORTEF | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N009866-001 | SOLU-CORTEF | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N009866-002 | SOLU-CORTEF | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N009866-003 | SOLU-CORTEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N009866-004 | SOLU-CORTEF | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009866-001 | SOLU-CORTEF | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009866-002 | SOLU-CORTEF | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009866-003 | SOLU-CORTEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009866-004 | SOLU-CORTEF | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009866-001 | SOLU-CORTEF | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009866-002 | SOLU-CORTEF | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009866-003 | SOLU-CORTEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009866-004 | SOLU-CORTEF | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N009866-001 | SOLU-CORTEF | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N009866-002 | SOLU-CORTEF | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N009866-003 | SOLU-CORTEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N009866-004 | SOLU-CORTEF | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N009866-001 | SOLU-CORTEF | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N009866-002 | SOLU-CORTEF | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N009866-003 | SOLU-CORTEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N009866-004 | SOLU-CORTEF | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N009866-001 | SOLU-CORTEF | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N009866-002 | SOLU-CORTEF | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N009866-003 | SOLU-CORTEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N009866-004 | SOLU-CORTEF | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N009866-001 | SOLU-CORTEF | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N009866-002 | SOLU-CORTEF | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N009866-003 | SOLU-CORTEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N009866-004 | SOLU-CORTEF | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N009866-001 | SOLU-CORTEF | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N009866-002 | SOLU-CORTEF | EQ 250MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N009866-003 | SOLU-CORTEF | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N009866-004 | SOLU-CORTEF | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N009866-001 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N009866-001 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N009866-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N009866-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009866-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N009866-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009866-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009866-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009866-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009866-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009866-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009866-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N009866-001 | AP | 1 | d06236e962d9… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N009866-001 | AP | 1 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Solu-Cortef | HYDROCORTISONE SODIUM SUCCINATE | Cardinal Health 107, LLC | f5bb0854-a477-4e59-914b-eeeaef92a596 | 2025-08-21 | Warnings, Adverse reactions | 009866 NDA009866 55154-3942 |
| Solu-Cortef | HYDROCORTISONE SODIUM SUCCINATE | ProPharma Distribution | 386942d3-c75f-25f1-e063-6394a90a5af2 | 2025-07-18 | Warnings, Adverse reactions | 009866 NDA009866 |
| SOLU-CORTEF | SOLU-CORTEF | HF Acquisition Co. LLC, DBA HealthFirst | 74f8ccd6-b263-7cc4-e053-2991aa0a896d | 2024-02-22 | Warnings, Adverse reactions | 009866 NDA009866 51662-1262 |
| SOLU-CORTEF | SOLU-CORTEF | HF Acquisition Co. LLC, DBA HealthFirst | 74f84173-a43f-7788-e053-2991aa0a8fb2 | 2024-02-22 | Warnings, Adverse reactions | 009866 NDA009866 51662-1261 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0009-0005 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0005 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0005 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0005 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0005 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0011 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0011 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0011 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0011 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0011 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0013 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0013 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0013 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0013 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0013 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0016 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0016 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0016 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0016 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0016 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0825 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0825 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0825 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0825 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0825 | Solu-Cortef | hydrocortisone sodium succinate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 51662-1261 | SOLU-CORTEF | SOLU-CORTEF | HF Acquisition Co. LLC, DBA HealthFirst | NDA | Current |
| 51662-1261 | SOLU-CORTEF | SOLU-CORTEF | HF Acquisition Co. LLC, DBA HealthFirst | NDA | Current |
| 51662-1261 | SOLU-CORTEF | SOLU-CORTEF | HF Acquisition Co. LLC, DBA HealthFirst | NDA | Current |
| 51662-1261 | SOLU-CORTEF | SOLU-CORTEF | HF Acquisition Co. LLC, DBA HealthFirst | NDA | Current |
| 51662-1262 | SOLU-CORTEF | SOLU-CORTEF | HF Acquisition Co. LLC, DBA HealthFirst | NDA | Current |
| 51662-1262 | SOLU-CORTEF | SOLU-CORTEF | HF Acquisition Co. LLC, DBA HealthFirst | NDA | Current |
| 51662-1262 | SOLU-CORTEF | SOLU-CORTEF | HF Acquisition Co. LLC, DBA HealthFirst | NDA | Current |
| 51662-1262 | SOLU-CORTEF | SOLU-CORTEF | HF Acquisition Co. LLC, DBA HealthFirst | NDA | Current |
| 55154-3942 | Solu-Cortef | hydrocortisone sodium succinate | Cardinal Health | NDA | Current |
| 55154-3942 | Solu-Cortef | hydrocortisone sodium succinate | Cardinal Health | NDA | Current |
| 55154-3942 | Solu-Cortef | hydrocortisone sodium succinate | Cardinal Health | NDA | Current |
| 55154-3942 | Solu-Cortef | hydrocortisone sodium succinate | Cardinal Health 107, LLC | NDA | Current |
| 55154-3942 | Solu-Cortef | hydrocortisone sodium succinate | Cardinal Health | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79123 | SUPPL | 2024-07-18 |
| 79122 | SUPPL | 2024-07-18 |
| 78705 | SUPPL | 2024-06-07 |
| 78671 | SUPPL | 2024-06-06 |
| 77121 | SUPPL | 2023-12-22 |
| 77103 | SUPPL | 2023-12-21 |
| 67698 | SUPPL | 2021-06-04 |
| 67627 | SUPPL | 2021-05-28 |
| 61017 | SUPPL | 2019-11-22 |
| 61014 | SUPPL | 2019-11-22 |
| 45260 | SUPPL | 2016-09-09 |
| 45259 | SUPPL | 2016-09-09 |
| 45255 | SUPPL | 2016-09-09 |
| 45254 | SUPPL | 2016-09-09 |
| 33008 | SUPPL | 2014-07-08 |
| 11884 | SUPPL | 2014-07-08 |
| 10734 | SUPPL | 2010-07-01 |
| 195 | SUPPL | 2010-06-28 |
| 11883 | SUPPL | 2009-11-09 |
| 194 | SUPPL | 2009-11-09 |
| 33007 | SUPPL | 2009-10-05 |
| 10733 | SUPPL | 2009-10-05 |