FDA Orange Book · active-ingredient family
Hydrocortisone sodium succinate
Hydrocortisone sodium succinate: 1 brand, 27 generics; first approved Mar 19, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 27 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
27
Listed patents
0
Presentations
32
Brand (NDA) products
Originator applications
- PHARMACIA AND UPJOHNNDA 009866—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 250MG BASE/VIAL INJECTABLE INJECTION Rx — EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx — EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx —
Generic (ANDA) products (27)
Abbreviated applications
- HYDROCORTISONE SODIUM SUCCINATEZYDUS PHARMSANDA 2171912026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP - HYDROCORTISONE SODIUM SUCCINATEAPOTEXANDA 2198562026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP - HYDROCORTISONE SODIUM SUCCINATECIPLAANDA 2140502024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP - HOSPIRAANDA 0406662006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ABBOTTANDA 0895801989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ABBOTTANDA 0895771989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ABBOTTANDA 0895781989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ABBOTTANDA 0895791989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEABRAXIS PHARMANDA 0886701984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEABRAXIS PHARMANDA 0886671984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEABRAXIS PHARMANDA 0887121984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEABRAXIS PHARMANDA 0886681984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEABRAXIS PHARMANDA 0886691984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEINTL MEDICATIONANDA 0875321982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ABBOTTANDA 085928—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 085932—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 085929—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 085930—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 085931—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEBAXTER HLTHCAREANDA 087569—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEBAXTER HLTHCAREANDA 086619—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEBAXTER HLTHCAREANDA 087567—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEBAXTER HLTHCAREANDA 087568—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEWATSON LABSANDA 084748—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEWATSON LABSANDA 084737—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEWATSON LABSANDA 084738—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HYDROCORTISONE SODIUM SUCCINATEWATSON LABSANDA 084747—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
45 yr 3 mo ago
Most recent approval
5 mo ago
Approvals span 1982–2026 across 28 FDA applications.
Brand (NDA) 14%
Generic (ANDA) 2796%
Hydrocortisone sodium succinate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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