FDA.reportPublic FDA data

HYDROCORTISONE SODIUM SUCCINATE for Injection, USP

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-05-08
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:18:43

Label at a glance#

ProductHydrocortisone sodium succinate
Active ingredientHYDROCORTISONE SODIUM SUCCINATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1966-1

Hydrocortisone sodium succinate for injection, USP

100 mg/vial

For Intravenous or Intramuscular use

Rx only

vial label
vial label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238755hydrocortisone sodium succinate 100 MG InjectionPSN1
238755hydrocortisone 100 MG InjectionSCD1
238755hydrocortisone (as hydrocortisone sodium succinate) 100 MG InjectionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1966-1Hydrocortisone sodium succinate1 in 1 CARTONINJECTION11
70771-1966-1Hydrocortisone sodium succinate2 mL in 1 VIALINJECTION21

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-196670771-1966-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONE SODIUM SUCCINATE50LQB69S1ZACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217191-001HYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2026-05-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217191-001AP

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217191-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2026-05-0784e616aacf4f…
2026-08-18 06:07:402026-07A217191-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2026-05-07caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217191-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTIONAP2026-05-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217191-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A217191-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217191-001AP1a50c72e98297…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone sodium succinateHYDROCORTISONE SODIUM SUCCINATEZydus Lifesciences Limitedd533ebee-9f1c-42d7-9808-ae5d5e55741b2026-05-08Exact identifier
ndc (package): 70771-1966-1
ndc (product): 70771-1966
ndc11 (package): 70771196601
spl id: 23cd0282-fb6b-4fb9-9b3a-0b23e8125625
spl set id: d533ebee-9f1c-42d7-9808-ae5d5e55741b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.