FDA.reportPublic FDA data

Hydrocortisone

Product NDC
0168-0020
11-digit product format
001680020
Labeler code
0168
Product ID
0168-0020_bfa9683a-fde4-462c-81b3-2ed398307a99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA080692
Marketing category
ANDA
Marketing start
1975-04-16
Substance
HYDROCORTISONE
Active strength
10 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocortisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui203105

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
0168-0020-16Hydrocortisone453.6 g in 1 JAROINTMENT453.68
0168-0020-31Hydrocortisone28.35 g in 1 TUBEOINTMENT28.358
0168-0020-31Hydrocortisone1 in 1 CARTONOINTMENT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0020-16GM - Gram0168-0020473ae6b3-5b43-49dc-bca6-b5b53f269b0e12012-07-24
0168-0020-31GM - Gram0168-0020108c058a-2724-48ab-aa7e-db6fc8b0f6ec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
hydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0020HYDROCORTISONE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 3 package rows20241204_31fbb576-0e76-471c-83c8-9e0125bc1791.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203105hydrocortisone 1 % Topical OintmentPSN31fbb576-0e76-471c-83c8-9e0125bc17918
203105hydrocortisone 0.01 MG/MG Topical OintmentSCD31fbb576-0e76-471c-83c8-9e0125bc17918
203105hydrocortisone 1 % Topical OintmentSY31fbb576-0e76-471c-83c8-9e0125bc17918
203105hydrocortisone 1 % Topical OintmentPSN39aa6953-9e27-4136-ab4a-e30db49ee81b1
203105hydrocortisone 0.01 MG/MG Topical OintmentSCD39aa6953-9e27-4136-ab4a-e30db49ee81b1
203105hydrocortisone 1 % Topical OintmentSY39aa6953-9e27-4136-ab4a-e30db49ee81b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0020-1600168002016453.6 g in 1 JAR (0168-0020-16) 453.6 g1975-04-160000-00-00NoNoCurrent
0168-0020-31001680020311 TUBE in 1 CARTON (0168-0020-31) / 28.35 g in 1 TUBE1 tube1975-04-160000-00-00NoNoCurrent