FDA.reportPublic FDA data

Hydrocortisone

Product NDC
0168-0146
11-digit product format
001680146
Labeler code
0168
Product ID
0168-0146_d4641721-bb32-4cf7-b17f-78886ffbce17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA081203
Marketing category
ANDA
Marketing start
1993-05-28
Substance
HYDROCORTISONE
Active strength
25 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A081203-001HYDROCORTISONEHYDROCORTISONE2.5%OINTMENT / TOPICALATRS1993-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A081203-001AT

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
2026-08-01 22:54:322026-06A081203-001HYDROCORTISONE2.5%OINTMENT / TOPICALATRS1993-05-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A081203-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCbcd103f3-3dc8-4394-b8fd-8f8ddb721f772026-01-28Adverse reactionsExact identifier
application applno (ANDA): 081203
application number: ANDA081203
ndc (product): 0168-0146
HydrocortisoneHYDROCORTISONEBryant Ranch Prepackc4013d86-e134-43c3-ad75-7e680a9d2ae72024-01-11Adverse reactionsExact identifier
application applno (ANDA): 081203
application number: ANDA081203

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103401Internal RxNorm lookup
310891Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bcd103f3-3dc8-4394-b8fd-8f8ddb721f77Available on FDA.report

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
0168-0146-16Hydrocortisone454 g in 1 JAROINTMENT45412
0168-0146-30Hydrocortisone29 g in 1 TUBEOINTMENT2912

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0146-16GM - Gram0168-0146d3fe1d75-6082-4de9-91c5-428909d0adc812012-07-24
0168-0146-30GM - Gram0168-0146a29ba772-f358-4fdc-92c0-4398cd7c12d712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
hydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
glycerinINACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4HYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
paraffinINACTIVE INGREDIENTI9O0E3H2ZEHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
petrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4HYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE OINTMENT [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0146HYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20241204_bcd103f3-3dc8-4394-b8fd-8f8ddb721f77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103401hydrocortisone 2.5 % Topical OintmentPSNc4013d86-e134-43c3-ad75-7e680a9d2ae7102
103401hydrocortisone 0.025 MG/MG Topical OintmentSCDc4013d86-e134-43c3-ad75-7e680a9d2ae7102
103401hydrocortisone 2.5 % Topical OintmentSYc4013d86-e134-43c3-ad75-7e680a9d2ae7102
310891hydrocortisone 2.5 % Topical CreamPSNbcd103f3-3dc8-4394-b8fd-8f8ddb721f7712
103401hydrocortisone 2.5 % Topical OintmentPSNbcd103f3-3dc8-4394-b8fd-8f8ddb721f7712
103401hydrocortisone 0.025 MG/MG Topical OintmentSCDbcd103f3-3dc8-4394-b8fd-8f8ddb721f7712
310891hydrocortisone 25 MG/ML Topical CreamSCDbcd103f3-3dc8-4394-b8fd-8f8ddb721f7712
310891hydrocortisone 2.5 % Topical CreamSYbcd103f3-3dc8-4394-b8fd-8f8ddb721f7712
103401hydrocortisone 2.5 % Topical OintmentSYbcd103f3-3dc8-4394-b8fd-8f8ddb721f7712
103401hydrocortisone 2.5 % Topical OintmentPSN4e4b7175-2046-4bfe-aee3-afafe08300f35
103401hydrocortisone 0.025 MG/MG Topical OintmentSCD4e4b7175-2046-4bfe-aee3-afafe08300f35
103401hydrocortisone 2.5 % Topical OintmentSY4e4b7175-2046-4bfe-aee3-afafe08300f35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0146-1600168014616454 g in 1 JAR (0168-0146-16) 454 g1993-05-280000-00-00NoNoCurrent
0168-0146-300016801463029 g in 1 TUBE (0168-0146-30) 29 g1993-05-280000-00-00NoNoCurrent