FDA.reportPublic FDA data

Solu-Cortef

Product NDC
0009-0016
11-digit product format
000090016
Labeler code
0009
Product ID
0009-0016_8512044a-4a54-4634-bb97-9e20126adc61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone sodium succinate
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA009866
Marketing category
NDA
Marketing start
1955-04-27
Substance
HYDROCORTISONE SODIUM SUCCINATE
Active strength
500 mg/4mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Solu-Cortef
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE SODIUM SUCCINATE500 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50LQB69S1Z
Rxcui105398, 238755, 1738586, 1738589, 1738590, 1738592, 1738594, 1738596

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
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
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
0009-0016-12Solu-Cortef4 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION429
0009-0016-12Solu-Cortef1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0016-12EA - Each0009-0016ed3ca8a1-536d-4548-a7a2-5a498bfb42f612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE SODIUM SUCCINATEACTIVE INGREDIENT50LQB69S1ZSOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY]15
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJSOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY]15
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74SOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY]15
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUSOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA AND UPJOHN COMPANY]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0016SOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]28Current NDC, Legacy NDC, 2 package rows20240731_65eefd58-b166-4d71-ade6-45c8fdf86922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238755hydrocortisone sodium succinate 100 MG InjectionPSN65eefd58-b166-4d71-ade6-45c8fdf8692229
1738586hydrocortisone sodium succinate 1000 MG InjectionPSN65eefd58-b166-4d71-ade6-45c8fdf8692229
1738590hydrocortisone sodium succinate 250 MG InjectionPSN65eefd58-b166-4d71-ade6-45c8fdf8692229
1738594hydrocortisone sodium succinate 500 MG InjectionPSN65eefd58-b166-4d71-ade6-45c8fdf8692229
105398Solu-CORTEF 100 MG InjectionPSN65eefd58-b166-4d71-ade6-45c8fdf8692229
1738589Solu-CORTEF 1000 MG InjectionPSN65eefd58-b166-4d71-ade6-45c8fdf8692229
1738592Solu-CORTEF 250 MG InjectionPSN65eefd58-b166-4d71-ade6-45c8fdf8692229
1738596Solu-CORTEF 500 MG InjectionPSN65eefd58-b166-4d71-ade6-45c8fdf8692229
105398hydrocortisone 100 MG Injection [Solu-Cortef]SBD65eefd58-b166-4d71-ade6-45c8fdf8692229
1738589hydrocortisone 1000 MG Injection [Solu-Cortef]SBD65eefd58-b166-4d71-ade6-45c8fdf8692229
1738592hydrocortisone 250 MG Injection [Solu-Cortef]SBD65eefd58-b166-4d71-ade6-45c8fdf8692229
1738596hydrocortisone 500 MG Injection [Solu-Cortef]SBD65eefd58-b166-4d71-ade6-45c8fdf8692229
238755hydrocortisone 100 MG InjectionSCD65eefd58-b166-4d71-ade6-45c8fdf8692229
1738586hydrocortisone 1000 MG InjectionSCD65eefd58-b166-4d71-ade6-45c8fdf8692229
1738590hydrocortisone 250 MG InjectionSCD65eefd58-b166-4d71-ade6-45c8fdf8692229
1738594hydrocortisone 500 MG InjectionSCD65eefd58-b166-4d71-ade6-45c8fdf8692229
238755hydrocortisone (as hydrocortisone sodium succinate) 100 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
1738586hydrocortisone (as hydrocortisone sodium succinate) 1000 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
1738590hydrocortisone (as hydrocortisone sodium succinate) 250 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
1738594hydrocortisone (as hydrocortisone sodium succinate) 500 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
105398Solu-Cortef (as hydrocortisone sodium succinate) 100 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
1738589Solu-Cortef (as hydrocortisone sodium succinate) 1000 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
1738592Solu-Cortef (as hydrocortisone sodium succinate) 250 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
1738596Solu-Cortef (as hydrocortisone sodium succinate) 500 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
105398Solu-Cortef 100 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
1738589Solu-Cortef 1000 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
1738592Solu-Cortef 250 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229
1738596Solu-Cortef 500 MG InjectionSY65eefd58-b166-4d71-ade6-45c8fdf8692229

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0009-0016-12000090016121 VIAL, SINGLE-DOSE in 1 CARTON (0009-0016-12) / 4 mL in 1 VIAL, SINGLE-DOSE1955-04-270000-00-00NoNoCurrent