Hydrocortisone

Product NDC: 0472-0321
11-digit product format: 004720321
Labeler code: 0472
Product ID: 0472-0321_9c878619-0930-40f2-b1a6-e92328a25fb2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: ANDA087795
Marketing category: ANDA
Marketing start: 2002-01-03
Marketing end: 2026-10-31
Substance: HYDROCORTISONE
Active strength: 10 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087795-001	HYDROCORTISONE	HYDROCORTISONE	1%	CREAM / TOPICAL	AT		1983-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087795-001	AT

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087795-001	HYDROCORTISONE	1%	CREAM / TOPICAL	AT	1983-05-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087795-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087795-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087795-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087795-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087795-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087795-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087795-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087795-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087795-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087795-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087795-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087795-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087795-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087795-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087795-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087795-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087795-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087795-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087795-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087795-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087795-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087795-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087795-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087795-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087795-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087795-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087795-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087795-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087795-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087795-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087795-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087795-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087795-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087795-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087795-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087795-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087795-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087795-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087795-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087795-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocortisone

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106258	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
aa9dba84-eb38-4ec3-8555-87c948bf2384	Available on FDA.report

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
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
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
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
597b1cfd-7b31-5048-62be-ca5cd740da2f	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
ec2149b3-5c6d-5344-f757-c86411073075	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	Strength	SPL version
0472-0321-26	Hydrocortisone	28.4 g in 1 TUBE	CREAM	28.4		8
0472-0321-26	Hydrocortisone	1 in 1 CARTON	CREAM	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-0321-26	GM - Gram	0472-0321	3a6682ec-de0c-4341-9c34-0368d72a4b14	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 [ACTAVIS MID ATLANTIC LLC]	2
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM HYDROCORTISONE OINTMENT [ACTAVIS MID ATLANTIC LLC]	2
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	HYDROCORTISONE CREAM [STAT RX USA LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCORTISONE CREAM [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0472-0321	HYDROCORTISONE CREAM [ACTAVIS PHARMA, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20200811_aa9dba84-eb38-4ec3-8555-87c948bf2384.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCORTISONE	HYDROCORTISONE	DIRECT RX	c28c3ceb-1807-b43b-e053-2995a90a2aba	2025-01-17	Adverse reactions	Exact identifier application applno (ANDA): 087795 application number: ANDA087795
Hydrocortisone	HYDROCORTISONE	Actavis Pharma, Inc.	aa9dba84-eb38-4ec3-8555-87c948bf2384	2020-07-01	Adverse reactions	Exact identifier application applno (ANDA): 087795 application number: ANDA087795 ndc (product): 0472-0321

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
106258	hydrocortisone 1 % Topical Cream	PSN	aa9dba84-eb38-4ec3-8555-87c948bf2384	8
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	aa9dba84-eb38-4ec3-8555-87c948bf2384	8
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	aa9dba84-eb38-4ec3-8555-87c948bf2384	8
106258	hydrocortisone 1 % Topical Cream	SY	aa9dba84-eb38-4ec3-8555-87c948bf2384	8
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	aa9dba84-eb38-4ec3-8555-87c948bf2384	8
106258	hydrocortisone 1 % Topical Cream	PSN	c28c3ceb-1807-b43b-e053-2995a90a2aba	3
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	c28c3ceb-1807-b43b-e053-2995a90a2aba	3
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	c28c3ceb-1807-b43b-e053-2995a90a2aba	3
106258	hydrocortisone 1 % Topical Cream	SY	c28c3ceb-1807-b43b-e053-2995a90a2aba	3
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	c28c3ceb-1807-b43b-e053-2995a90a2aba	3
106258	hydrocortisone 1 % Topical Cream	PSN	556d85f7-4d6c-4c0e-89d5-bc1673b4dfaf	1
106258	hydrocortisone 1 % Topical Cream	PSN	1fc033bf-2550-d9ac-e063-6394a90aca75	1
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	556d85f7-4d6c-4c0e-89d5-bc1673b4dfaf	1
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	1fc033bf-2550-d9ac-e063-6394a90aca75	1
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	556d85f7-4d6c-4c0e-89d5-bc1673b4dfaf	1
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	1fc033bf-2550-d9ac-e063-6394a90aca75	1
106258	hydrocortisone 1 % Topical Cream	SY	556d85f7-4d6c-4c0e-89d5-bc1673b4dfaf	1
106258	hydrocortisone 1 % Topical Cream	SY	1fc033bf-2550-d9ac-e063-6394a90aca75	1
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	556d85f7-4d6c-4c0e-89d5-bc1673b4dfaf	1
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	1fc033bf-2550-d9ac-e063-6394a90aca75	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-0321-26	00472032126	1 TUBE in 1 CARTON (0472-0321-26) / 28.4 g in 1 TUBE	1 tube	2002-01-03	2026-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCORTISONE	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	3
HYDROCORTISONE CREAM USP, 1% TOPICAL CORTICOSTEROID Rx only	RedPharm Drug	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
HYDROCORTISONE CREAM USP, 1% TOPICAL CORTICOSTEROID Rx only	Actavis Pharma, Inc.	2020-08-10	HUMAN PRESCRIPTION DRUG LABEL	7
HYDROCORTISONE - STAT Rx USA LLC \| PSS World Medical Inc.	STAT Rx USA LLC \| PSS World Medical Inc.	2012-07-03	HUMAN PRESCRIPTION DRUG LABEL	1