FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ
Rxcui310891, 1440936

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
64980-324-30PROCTOZONE-HC1 in 1 CARTONCREAM18
64980-324-30PROCTOZONE-HC30 g in 1 TUBECREAM308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-324PROCTOZONE-HC (HYDROCORTISONE 2.5%) CREAM [RISING PHARMA HOLDINGS, INC.]8Current NDC, Legacy NDC, 2 package rows20230625_fb5746ff-3ff1-4874-a827-4694133641b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310891hydrocortisone 2.5 % Topical CreamPSN1cf056c4-01c6-424a-a436-779417eb8244106
1440936Proctozone HC 2.5 % Topical CreamPSN1cf056c4-01c6-424a-a436-779417eb8244106
1440936hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]SBD1cf056c4-01c6-424a-a436-779417eb8244106
310891hydrocortisone 25 MG/ML Topical CreamSCD1cf056c4-01c6-424a-a436-779417eb8244106
310891hydrocortisone 2.5 % Topical CreamSY1cf056c4-01c6-424a-a436-779417eb8244106
1440936Proctozone HC 2.5 % Topical CreamSY1cf056c4-01c6-424a-a436-779417eb8244106
1440936Proctozone HC 25 MG/ML Topical CreamSY1cf056c4-01c6-424a-a436-779417eb8244106
310891hydrocortisone 2.5 % Topical CreamPSNbfafb095-6dd1-4a38-88a7-16f6e0aa8de5105
1440936Proctozone HC 2.5 % Topical CreamPSNbfafb095-6dd1-4a38-88a7-16f6e0aa8de5105
1440936hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]SBDbfafb095-6dd1-4a38-88a7-16f6e0aa8de5105
310891hydrocortisone 25 MG/ML Topical CreamSCDbfafb095-6dd1-4a38-88a7-16f6e0aa8de5105
310891hydrocortisone 2.5 % Topical CreamSYbfafb095-6dd1-4a38-88a7-16f6e0aa8de5105
1440936Proctozone HC 2.5 % Topical CreamSYbfafb095-6dd1-4a38-88a7-16f6e0aa8de5105
1440936Proctozone HC 25 MG/ML Topical CreamSYbfafb095-6dd1-4a38-88a7-16f6e0aa8de5105
310891hydrocortisone 2.5 % Topical CreamPSNd1917a67-9735-46e2-9065-8f9f64ebefb9100
1440936Proctozone HC 2.5 % Topical CreamPSNd1917a67-9735-46e2-9065-8f9f64ebefb9100
1440936hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]SBDd1917a67-9735-46e2-9065-8f9f64ebefb9100
310891hydrocortisone 25 MG/ML Topical CreamSCDd1917a67-9735-46e2-9065-8f9f64ebefb9100
310891hydrocortisone 2.5 % Topical CreamSYd1917a67-9735-46e2-9065-8f9f64ebefb9100
1440936Proctozone HC 2.5 % Topical CreamSYd1917a67-9735-46e2-9065-8f9f64ebefb9100
1440936Proctozone HC 25 MG/ML Topical CreamSYd1917a67-9735-46e2-9065-8f9f64ebefb9100
310891hydrocortisone 2.5 % Topical CreamPSNfb5746ff-3ff1-4874-a827-4694133641b98
1440936Proctozone HC 2.5 % Topical CreamPSNfb5746ff-3ff1-4874-a827-4694133641b98
1440936hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]SBDfb5746ff-3ff1-4874-a827-4694133641b98
310891hydrocortisone 25 MG/ML Topical CreamSCDfb5746ff-3ff1-4874-a827-4694133641b98
310891hydrocortisone 2.5 % Topical CreamSYfb5746ff-3ff1-4874-a827-4694133641b98
1440936Proctozone HC 2.5 % Topical CreamSYfb5746ff-3ff1-4874-a827-4694133641b98
1440936Proctozone HC 25 MG/ML Topical CreamSYfb5746ff-3ff1-4874-a827-4694133641b98
310891hydrocortisone 2.5 % Topical CreamPSN5f055f94-b213-431b-897e-1c439660f1587
1440936Proctozone HC 2.5 % Topical CreamPSN5f055f94-b213-431b-897e-1c439660f1587
1440936hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]SBD5f055f94-b213-431b-897e-1c439660f1587
310891hydrocortisone 25 MG/ML Topical CreamSCD5f055f94-b213-431b-897e-1c439660f1587
310891hydrocortisone 2.5 % Topical CreamSY5f055f94-b213-431b-897e-1c439660f1587
1440936Proctozone HC 2.5 % Topical CreamSY5f055f94-b213-431b-897e-1c439660f1587
1440936Proctozone HC 25 MG/ML Topical CreamSY5f055f94-b213-431b-897e-1c439660f1587
310891hydrocortisone 2.5 % Topical CreamPSNe5828177-9762-f84e-e053-2995a90aa1dd1
1440936Proctozone HC 2.5 % Topical CreamPSNe5828177-9762-f84e-e053-2995a90aa1dd1
1440936hydrocortisone 25 MG/ML Topical Cream [Proctozone HC]SBDe5828177-9762-f84e-e053-2995a90aa1dd1
310891hydrocortisone 25 MG/ML Topical CreamSCDe5828177-9762-f84e-e053-2995a90aa1dd1
310891hydrocortisone 2.5 % Topical CreamSYe5828177-9762-f84e-e053-2995a90aa1dd1
1440936Proctozone HC 2.5 % Topical CreamSYe5828177-9762-f84e-e053-2995a90aa1dd1
1440936Proctozone HC 25 MG/ML Topical CreamSYe5828177-9762-f84e-e053-2995a90aa1dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-324-30649800324301 TUBE in 1 CARTON (64980-324-30) / 30 g in 1 TUBE1 tube2015-08-030000-00-00NoNoCurrent