FDA.reportPublic FDA data

pramosone

Product NDC
54766-763
Requested package NDC
54766-763-04
11-digit product format
547660763
Labeler code
54766
Product ID
54766-763_6063a847-17e1-7fa2-e053-2a91aa0abccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone acetate and pramoxine hydrochloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sebela Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-08-05
Marketing end
0000-00-00
Substance
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength
10 mg/g; mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE10 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3X7931PO74Internal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234317Internal RxNorm lookup
1234322Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4d85400-3bb3-11e5-830e-0002a5d5c51bAvailable 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54766-763-04GM - Gram54766-763ea65999c-1a72-4f92-89f9-e12b42352b3e12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74PRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5PRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJPRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.]1
PRAMOXINEACTIVE MOIETY068X84E056PRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UPRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5APRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54766-763PRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.]4Legacy NDC20241114_d4d85400-3bb3-11e5-830e-0002a5d5c51b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.d4d85400-3bb3-11e5-830e-0002a5d5c51b2026-05-29Adverse reactionsExact identifier
ndc (package): 54766-763-04
ndc (product): 54766-763
ndc11 (package): 54766076304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54766-763-045476607630428.4 g in 1 TUBE (54766-763-04) 28.4 g2015-08-050000-00-00NoNoCurrent