PROCTOZONE-HC

Product NDC: 64980-324
11-digit product format: 649800324
Labeler code: 64980
Product ID: 64980-324_d929629c-8c27-4e73-a1ae-4e121ad267de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocortisone 2.5%
Dosage form: CREAM
Route: TOPICAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA040879
Marketing category: ANDA
Marketing start: 2015-08-03
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040879-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT		2010-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040879-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040879-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	2010-08-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040879-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040879-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040879-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040879-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040879-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040879-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040879-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040879-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040879-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040879-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040879-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040879-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040879-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040879-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040879-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040879-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040879-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040879-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040879-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040879-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040879-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040879-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040879-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040879-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040879-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040879-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040879-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040879-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040879-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040879-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040879-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040879-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040879-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040879-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040879-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040879-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040879-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040879-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040879-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040879-001	AT	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: PROCTOZONE-HC
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	25 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310891	Internal RxNorm lookup
1440936	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
fb5746ff-3ff1-4874-a827-4694133641b9	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
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	Strength	SPL version
64980-324-30	PROCTOZONE-HC	1 in 1 CARTON	CREAM	1		8
64980-324-30	PROCTOZONE-HC	30 g in 1 TUBE	CREAM	30		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-324-30	GM - Gram	64980-324	c330fc6a-a76b-45cf-951f-9ab5ecf7b64e	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROCTOZONE (HYDROCORTISONE 2.5%) CREAM [RISING PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-324	PROCTOZONE-HC (HYDROCORTISONE 2.5%) CREAM [RISING PHARMA HOLDINGS, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20230625_fb5746ff-3ff1-4874-a827-4694133641b9.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Preferred Pharmaceuticals, Inc.	5f055f94-b213-431b-897e-1c439660f158	2026-08-21	Adverse reactions	Exact identifier application applno (ANDA): 040879 application number: ANDA040879
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Bryant Ranch Prepack	1cf056c4-01c6-424a-a436-779417eb8244	2024-08-06	Adverse reactions	Exact identifier application applno (ANDA): 040879 application number: ANDA040879
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Bryant Ranch Prepack	bfafb095-6dd1-4a38-88a7-16f6e0aa8de5	2023-12-08	Adverse reactions	Exact identifier application applno (ANDA): 040879 application number: ANDA040879
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Bryant Ranch Prepack	d1917a67-9735-46e2-9065-8f9f64ebefb9	2023-10-04	Adverse reactions	Exact identifier application applno (ANDA): 040879 application number: ANDA040879
PROCTOZONE-HC	HYDROCORTISONE 2.5%	Rising Pharma Holdings, Inc.	fb5746ff-3ff1-4874-a827-4694133641b9	2023-05-07	Adverse reactions	Exact identifier application applno (ANDA): 040879 application number: ANDA040879 ndc (product): 64980-324

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	1cf056c4-01c6-424a-a436-779417eb8244	106
1440936	Proctozone HC 2.5 % Topical Cream	PSN	1cf056c4-01c6-424a-a436-779417eb8244	106
1440936	hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]	SBD	1cf056c4-01c6-424a-a436-779417eb8244	106
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	1cf056c4-01c6-424a-a436-779417eb8244	106
310891	hydrocortisone 2.5 % Topical Cream	SY	1cf056c4-01c6-424a-a436-779417eb8244	106
1440936	Proctozone HC 2.5 % Topical Cream	SY	1cf056c4-01c6-424a-a436-779417eb8244	106
1440936	Proctozone HC 25 MG/ML Topical Cream	SY	1cf056c4-01c6-424a-a436-779417eb8244	106
310891	hydrocortisone 2.5 % Topical Cream	PSN	bfafb095-6dd1-4a38-88a7-16f6e0aa8de5	105
1440936	Proctozone HC 2.5 % Topical Cream	PSN	bfafb095-6dd1-4a38-88a7-16f6e0aa8de5	105
1440936	hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]	SBD	bfafb095-6dd1-4a38-88a7-16f6e0aa8de5	105
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	bfafb095-6dd1-4a38-88a7-16f6e0aa8de5	105
310891	hydrocortisone 2.5 % Topical Cream	SY	bfafb095-6dd1-4a38-88a7-16f6e0aa8de5	105
1440936	Proctozone HC 2.5 % Topical Cream	SY	bfafb095-6dd1-4a38-88a7-16f6e0aa8de5	105
1440936	Proctozone HC 25 MG/ML Topical Cream	SY	bfafb095-6dd1-4a38-88a7-16f6e0aa8de5	105
310891	hydrocortisone 2.5 % Topical Cream	PSN	d1917a67-9735-46e2-9065-8f9f64ebefb9	100
1440936	Proctozone HC 2.5 % Topical Cream	PSN	d1917a67-9735-46e2-9065-8f9f64ebefb9	100
1440936	hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]	SBD	d1917a67-9735-46e2-9065-8f9f64ebefb9	100
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	d1917a67-9735-46e2-9065-8f9f64ebefb9	100
310891	hydrocortisone 2.5 % Topical Cream	SY	d1917a67-9735-46e2-9065-8f9f64ebefb9	100
1440936	Proctozone HC 2.5 % Topical Cream	SY	d1917a67-9735-46e2-9065-8f9f64ebefb9	100
1440936	Proctozone HC 25 MG/ML Topical Cream	SY	d1917a67-9735-46e2-9065-8f9f64ebefb9	100
310891	hydrocortisone 2.5 % Topical Cream	PSN	fb5746ff-3ff1-4874-a827-4694133641b9	8
1440936	Proctozone HC 2.5 % Topical Cream	PSN	fb5746ff-3ff1-4874-a827-4694133641b9	8
1440936	hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]	SBD	fb5746ff-3ff1-4874-a827-4694133641b9	8
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	fb5746ff-3ff1-4874-a827-4694133641b9	8
310891	hydrocortisone 2.5 % Topical Cream	SY	fb5746ff-3ff1-4874-a827-4694133641b9	8
1440936	Proctozone HC 2.5 % Topical Cream	SY	fb5746ff-3ff1-4874-a827-4694133641b9	8
1440936	Proctozone HC 25 MG/ML Topical Cream	SY	fb5746ff-3ff1-4874-a827-4694133641b9	8
310891	hydrocortisone 2.5 % Topical Cream	PSN	5f055f94-b213-431b-897e-1c439660f158	7
1440936	Proctozone HC 2.5 % Topical Cream	PSN	5f055f94-b213-431b-897e-1c439660f158	7
1440936	hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]	SBD	5f055f94-b213-431b-897e-1c439660f158	7
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	5f055f94-b213-431b-897e-1c439660f158	7
310891	hydrocortisone 2.5 % Topical Cream	SY	5f055f94-b213-431b-897e-1c439660f158	7
1440936	Proctozone HC 2.5 % Topical Cream	SY	5f055f94-b213-431b-897e-1c439660f158	7
1440936	Proctozone HC 25 MG/ML Topical Cream	SY	5f055f94-b213-431b-897e-1c439660f158	7
310891	hydrocortisone 2.5 % Topical Cream	PSN	e5828177-9762-f84e-e053-2995a90aa1dd	1
1440936	Proctozone HC 2.5 % Topical Cream	PSN	e5828177-9762-f84e-e053-2995a90aa1dd	1
1440936	hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]	SBD	e5828177-9762-f84e-e053-2995a90aa1dd	1
310891	hydrocortisone 25 MG/ML Topical Cream	SCD	e5828177-9762-f84e-e053-2995a90aa1dd	1
310891	hydrocortisone 2.5 % Topical Cream	SY	e5828177-9762-f84e-e053-2995a90aa1dd	1
1440936	Proctozone HC 2.5 % Topical Cream	SY	e5828177-9762-f84e-e053-2995a90aa1dd	1
1440936	Proctozone HC 25 MG/ML Topical Cream	SY	e5828177-9762-f84e-e053-2995a90aa1dd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-324-30	64980032430	1 TUBE in 1 CARTON (64980-324-30) / 30 g in 1 TUBE	1 tube	2015-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROCTOZONE–HC® 2.5% (Hydrocortisone Cream, USP 2.5%) FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE	Preferred Pharmaceuticals, Inc.	2026-08-21	HUMAN PRESCRIPTION DRUG LABEL	8
PROCTOZONE–HC® 2.5% (Hydrocortisone Cream, USP 2.5%) FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE	Bryant Ranch Prepack	2024-08-06	HUMAN PRESCRIPTION DRUG LABEL	106
PROCTOZONE–HC® 2.5% (Hydrocortisone Cream, USP 2.5%) FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE	Bryant Ranch Prepack	2023-12-08	HUMAN PRESCRIPTION DRUG LABEL	105
PROCTOZONE–HC® 2.5% (Hydrocortisone Cream, USP 2.5%) FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE	Bryant Ranch Prepack	2023-10-04	HUMAN PRESCRIPTION DRUG LABEL	100
PROCTOZONE–HC® 2.5% (Hydrocortisone Cream, USP 2.5%) FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE	Rising Pharma Holdings, Inc. \| Lyne Laboratories, Inc.	2023-05-07	Human Prescription Drug Label	8
PROCTOZONE–HC® 2.5% (Hydrocortisone Cream, USP 2.5%) FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE	NuCare Pharmaceuticals,Inc.	2022-08-05	HUMAN PRESCRIPTION DRUG LABEL	1