Hydrocortisone

Product NDC: 45802-004
11-digit product format: 458020004
Labeler code: 45802
Product ID: 45802-004_4b485448-cd59-492b-89cf-8b0582751e44
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA085025
Marketing category: ANDA
Marketing start: 2006-03-31
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	25 mg/g

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	WI4X0X7BPJ
Rxcui	103401, 310891

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45802-004-02	Hydrocortisone	1 in 1 CARTON	CREAM	1	13
45802-004-02	Hydrocortisone	20 g in 1 TUBE	CREAM	20	13
45802-004-03	Hydrocortisone	1 in 1 CARTON	CREAM	1	13
45802-004-03	Hydrocortisone	28 g in 1 TUBE	CREAM	28	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-004-02	GM - Gram	45802-004	86cfda94-a7d1-4125-93a7-4ef008d22e87	1	2012-07-24
45802-004-03	GM - Gram	45802-004	6d342a99-d8bc-4b23-acf0-dc88ee955e38	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PERRIGO NEW YORK INC]	6
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS, INC.]	3
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-004	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]	12	Current NDC, Legacy NDC, 4 package rows	20240430_7ba59aa6-b828-4048-bf86-90c90d9894a0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310891	hydrocortisone 2.5 % Topical Cream	PSN	b33f51f5-7506-43d3-863b-406dc5c7d167	104
310891	hydrocortisone 2.5 % Topical Cream	PSN	84c95149-9064-4b4d-a7d0-93dfefca1370	104
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	84c95149-9064-4b4d-a7d0-93dfefca1370	104
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	b33f51f5-7506-43d3-863b-406dc5c7d167	104
310891	hydrocortisone 2.5 % Topical Cream	SY	84c95149-9064-4b4d-a7d0-93dfefca1370	104
310891	hydrocortisone 2.5 % Topical Cream	SY	b33f51f5-7506-43d3-863b-406dc5c7d167	104
310891	hydrocortisone 2.5 % Topical Cream	PSN	2352bb58-a624-4c5e-8966-f68817c30470	103
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	2352bb58-a624-4c5e-8966-f68817c30470	103
310891	hydrocortisone 2.5 % Topical Cream	SY	2352bb58-a624-4c5e-8966-f68817c30470	103
310891	hydrocortisone 2.5 % Topical Cream	PSN	bb959c6f-7c9a-43c5-a45b-2ad9a87baa88	18
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	bb959c6f-7c9a-43c5-a45b-2ad9a87baa88	18
310891	hydrocortisone 2.5 % Topical Cream	SY	bb959c6f-7c9a-43c5-a45b-2ad9a87baa88	18
310891	hydrocortisone 2.5 % Topical Cream	PSN	5d7ae83f-e9ad-4805-812c-919065cb69af	14
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	5d7ae83f-e9ad-4805-812c-919065cb69af	14
310891	hydrocortisone 2.5 % Topical Cream	SY	5d7ae83f-e9ad-4805-812c-919065cb69af	14
310891	hydrocortisone 2.5 % Topical Cream	PSN	058bb2ff-ff51-4a3b-ba47-cb02272d0631	13
310891	hydrocortisone 2.5 % Topical Cream	PSN	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
103401	hydrocortisone 2.5 % Topical Ointment	PSN	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
103401	hydrocortisone 0.025 MG/MG Topical Ointment	SCD	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	058bb2ff-ff51-4a3b-ba47-cb02272d0631	13
310891	hydrocortisone 2.5 % Topical Cream	SY	058bb2ff-ff51-4a3b-ba47-cb02272d0631	13
310891	hydrocortisone 2.5 % Topical Cream	SY	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
103401	hydrocortisone 2.5 % Topical Ointment	SY	7ba59aa6-b828-4048-bf86-90c90d9894a0	13
310891	hydrocortisone 2.5 % Topical Cream	PSN	f0e66726-946b-4f63-b457-2851dc69e6b4	11
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	f0e66726-946b-4f63-b457-2851dc69e6b4	11
310891	hydrocortisone 2.5 % Topical Cream	SY	f0e66726-946b-4f63-b457-2851dc69e6b4	11
310891	hydrocortisone 2.5 % Topical Cream	PSN	5bb279c6-d572-43a2-e053-2991aa0a686e	5
310891	hydrocortisone 2.5 % Topical Cream	PSN	656b46de-e3db-4ca0-b5e6-7487cbe9f220	5
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	656b46de-e3db-4ca0-b5e6-7487cbe9f220	5
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	5bb279c6-d572-43a2-e053-2991aa0a686e	5
310891	hydrocortisone 2.5 % Topical Cream	SY	5bb279c6-d572-43a2-e053-2991aa0a686e	5
310891	hydrocortisone 2.5 % Topical Cream	SY	656b46de-e3db-4ca0-b5e6-7487cbe9f220	5
310891	hydrocortisone 2.5 % Topical Cream	PSN	eb0b48d9-edeb-432c-836c-080ebce97c70	3
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	eb0b48d9-edeb-432c-836c-080ebce97c70	3
310891	hydrocortisone 2.5 % Topical Cream	SY	eb0b48d9-edeb-432c-836c-080ebce97c70	3
310891	hydrocortisone 2.5 % Topical Cream	PSN	19b09776-165a-9579-e063-6294a90a9d39	2
310891	hydrocortisone 2.5 % Topical Cream	PSN	cd3809fc-4283-f915-e053-2995a90a381e	2
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	cd3809fc-4283-f915-e053-2995a90a381e	2
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	19b09776-165a-9579-e063-6294a90a9d39	2
310891	hydrocortisone 2.5 % Topical Cream	SY	cd3809fc-4283-f915-e053-2995a90a381e	2
310891	hydrocortisone 2.5 % Topical Cream	SY	19b09776-165a-9579-e063-6294a90a9d39	2
310891	hydrocortisone 2.5 % Topical Cream	PSN	c98554d7-41dc-4b24-ae22-a06b48e1a7b5	1
310891	hydrocortisone 2.5 % Topical Cream	PSN	de26959d-8a42-47a0-b694-1aa5a686a8d7	1
310891	hydrocortisone 2.5 % Topical Cream	PSN	e1166b3a-a304-4030-ab51-eb55c6e91afd	1
310891	hydrocortisone 2.5 % Topical Cream	PSN	395df967-7532-4de5-a8b3-b34a4b3ace84	1
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	de26959d-8a42-47a0-b694-1aa5a686a8d7	1
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	e1166b3a-a304-4030-ab51-eb55c6e91afd	1
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	c98554d7-41dc-4b24-ae22-a06b48e1a7b5	1
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	395df967-7532-4de5-a8b3-b34a4b3ace84	1
310891	hydrocortisone 2.5 % Topical Cream	SY	c98554d7-41dc-4b24-ae22-a06b48e1a7b5	1
310891	hydrocortisone 2.5 % Topical Cream	SY	de26959d-8a42-47a0-b694-1aa5a686a8d7	1
310891	hydrocortisone 2.5 % Topical Cream	SY	e1166b3a-a304-4030-ab51-eb55c6e91afd	1
310891	hydrocortisone 2.5 % Topical Cream	SY	395df967-7532-4de5-a8b3-b34a4b3ace84	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-004-02	45802000402	1 TUBE in 1 CARTON (45802-004-02) / 20 g in 1 TUBE	1 tube	2007-01-31	0000-00-00	No	No	Current
45802-004-03	45802000403	1 TUBE in 1 CARTON (45802-004-03) / 28 g in 1 TUBE	1 tube	2006-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Preferred Pharmaceuticals, Inc.	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	13
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Bryant Ranch Prepack	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	103
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	REMEDYREPACK INC.	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	11
Hydrocortisone Cream	Direct_Rx	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	2
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	A-S Medication Solutions	2026-02-18	HUMAN PRESCRIPTION DRUG LABEL	18
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Padagis Israel Pharmaceuticals Ltd	2026-01-06	HUMAN PRESCRIPTION DRUG LABEL	13
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	A-S Medication Solutions	2024-10-02	HUMAN PRESCRIPTION DRUG LABEL	14
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Bryant Ranch Prepack	2024-08-22	HUMAN PRESCRIPTION DRUG LABEL	104
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	NuCare Pharmaceuticals,Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	5
HYDROCORTISONE CREAM USP, 2.5%	Proficient Rx LP	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	1
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Bryant Ranch Prepack	2023-07-18	HUMAN PRESCRIPTION DRUG LABEL	104
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	NuCare Pharmaceuticals,Inc.	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	2
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	RPK Pharmaceuticals, Inc.	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	1
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Central Texas Community Health Centers \| Travis County Healthcare District	2018-04-26	HUMAN PRESCRIPTION DRUG LABEL	3
HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%	Aidarex Pharmaceuticals LLC	2017-02-28	HUMAN PRESCRIPTION DRUG LABEL	1
HYDROCORTISONE OINTMENT USP, 2.5% HYDROCORTISONE CREAM USP, 2.5%	Rebel Distributors Corp	2012-03-06	HUMAN PRESCRIPTION DRUG LABEL	1

Hydrocortisone

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#