FDA.reportPublic FDA data

Hydrocortisone

Product NDC
51672-3003
11-digit product format
516723003
Labeler code
51672
Product ID
51672-3003_402e1830-5f8f-5dcc-e063-6294a90a652b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA088799
Marketing category
ANDA
Marketing start
2005-04-28
Substance
HYDROCORTISONE
Active strength
25 mg/g
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
Hydrocortisone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui106258, 310891

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
51672-3003-0Hydrocortisone1 in 1 CARTONCREAM18
51672-3003-0Hydrocortisone20 g in 1 TUBECREAM208
51672-3003-2Hydrocortisone1 in 1 CARTONCREAM18
51672-3003-2Hydrocortisone28.35 g in 1 TUBECREAM28.358

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-3003-2GM - Gram51672-300356359cbc-d0e5-4fd6-b2c4-b483640c103312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HEHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbic acidINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
hydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [DIRECT RX]1
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [DIRECT RX]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE CREAM [DIRECT RX]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE CREAM [DIRECT RX]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEHYDROCORTISONE CREAM [DIRECT RX]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [DIRECT RX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE CREAM [DIRECT RX]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE CREAM [DIRECT RX]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MHYDROCORTISONE CREAM [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE CREAM [DIRECT RX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM [DIRECT RX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE CREAM [DIRECT RX]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE CREAM [DIRECT RX]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [AIDAREX PHARMACEUTICALS LLC]1
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-3003HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 4 package rows20231219_e4f22e9c-cf38-473a-8f7d-8da7fd696f76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNe4f22e9c-cf38-473a-8f7d-8da7fd696f768
310891hydrocortisone 2.5 % Topical CreamPSNe4f22e9c-cf38-473a-8f7d-8da7fd696f768
106258hydrocortisone 10 MG/ML Topical CreamSCDe4f22e9c-cf38-473a-8f7d-8da7fd696f768
310891hydrocortisone 25 MG/ML Topical CreamSCDe4f22e9c-cf38-473a-8f7d-8da7fd696f768
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYe4f22e9c-cf38-473a-8f7d-8da7fd696f768
106258hydrocortisone 1 % Topical CreamSYe4f22e9c-cf38-473a-8f7d-8da7fd696f768
106258hydrocortisone 1 GM per 100 GM Topical CreamSYe4f22e9c-cf38-473a-8f7d-8da7fd696f768
310891hydrocortisone 2.5 % Topical CreamSYe4f22e9c-cf38-473a-8f7d-8da7fd696f768
310891hydrocortisone 2.5 % Topical CreamPSN3d017594-3a00-40ba-b392-1699992fa1b16
310891hydrocortisone 25 MG/ML Topical CreamSCD3d017594-3a00-40ba-b392-1699992fa1b16
310891hydrocortisone 2.5 % Topical CreamSY3d017594-3a00-40ba-b392-1699992fa1b16
310891hydrocortisone 2.5 % Topical CreamPSN02ab1006-c7c8-42c9-bda8-62c9d71425213
310891hydrocortisone 2.5 % Topical CreamPSNac3947c9-5a66-b4e7-e053-2995a90a6f673
310891hydrocortisone 25 MG/ML Topical CreamSCD02ab1006-c7c8-42c9-bda8-62c9d71425213
310891hydrocortisone 25 MG/ML Topical CreamSCDac3947c9-5a66-b4e7-e053-2995a90a6f673
310891hydrocortisone 2.5 % Topical CreamSYac3947c9-5a66-b4e7-e053-2995a90a6f673
310891hydrocortisone 2.5 % Topical CreamSY02ab1006-c7c8-42c9-bda8-62c9d71425213
310891hydrocortisone 2.5 % Topical CreamPSN7c27282c-42f2-4682-b75f-cdd60ac533c31
310891hydrocortisone 25 MG/ML Topical CreamSCD7c27282c-42f2-4682-b75f-cdd60ac533c31
310891hydrocortisone 2.5 % Topical CreamSY7c27282c-42f2-4682-b75f-cdd60ac533c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-3003-0516723003001 TUBE in 1 CARTON (51672-3003-0) / 20 g in 1 TUBE1 tube2005-04-280000-00-00NoNoCurrent
51672-3003-2516723003021 TUBE in 1 CARTON (51672-3003-2) / 28.35 g in 1 TUBE1 tube2005-04-280000-00-00NoNoCurrent