FDA.reportPublic FDA data

Analpram HC

Product NDC
54766-799
11-digit product format
547660799
Labeler code
54766
Product ID
54766-799_43146b87-2f75-b0a4-e063-6294a90a25c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone acetate and pramoxine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sebela Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-08-07
Marketing end
2026-11-30
Substance
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Active strength
25; 10 mg/g; mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Analpram HC

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE25 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, 88AYB867L5
Rxcui1294025, 1362211

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54766-799-042020-10-14C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-042020-10-14C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-642020-10-14C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-642020-10-14C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-652020-10-14C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-652020-10-14C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-712020-10-14C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-712020-10-14C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-722020-10-14C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-722020-10-14C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-042020-01-31C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-042020-01-31C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-642020-01-31C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-642020-01-31C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-652020-01-31C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-652020-01-31C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-712020-01-31C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-712020-01-31C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-722020-01-31C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%
54766-799-722020-01-31C16284748780-19d75b9d0-9a42-f424-e053-dadaa90a57ceAnalpram HC ® (hydrocortisone acetate 2.5% pramoxine HCl 1%) Cream 2.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54766-799-04Analpram HC28.4 g in 1 TUBE, WITH APPLICATORCREAM28.49
54766-799-33Analpram HC4 g in 1 TUBE, WITH APPLICATORCREAM49
54766-799-36Analpram HC4 g in 1 TUBE, WITH APPLICATORCREAM49
54766-799-64Analpram HC30 in 1 CARTONCREAM309
54766-799-65Analpram HC12 in 1 CARTONCREAM129
54766-799-71Analpram HC30 in 1 CARTONCREAM309
54766-799-72Analpram HC12 in 1 CARTONCREAM129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54766-799-04GM - Gram54766-79922f30c36-37bb-498d-a7c0-0f1dc210b91912015-09-10
54766-799-36GM - Gram54766-799778228f1-06b8-4c66-b017-151ba72b8df412019-04-11
54766-799-64GM - Gram54766-7996e2e1a02-f671-461a-97cc-7adf30e4871012015-09-10
54766-799-65GM - Gram54766-79910c92249-b4a5-46b6-aa86-faedaad1de9412015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
PRAMOXINEACTIVE MOIETY068X84E056ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
TROLAMINE LAURYL SULFATEINACTIVE INGREDIENTE8458C1KAAANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54766-799ANALPRAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 7 package rows20241114_fecf8380-3bb5-11e5-98c5-0002a5d5c51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362211Analpram 2.5 % / 1 % Rectal CreamPSNfecf8380-3bb5-11e5-98c5-0002a5d5c51b9
1294025hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Rectal CreamPSNfecf8380-3bb5-11e5-98c5-0002a5d5c51b9
1362211hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]SBDfecf8380-3bb5-11e5-98c5-0002a5d5c51b9
1294025hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCDfecf8380-3bb5-11e5-98c5-0002a5d5c51b9
1362211Analpram HC 2.5 % / 1 % (hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % ) Rectal CreamSYfecf8380-3bb5-11e5-98c5-0002a5d5c51b9
1294025hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Rectal CreamSYfecf8380-3bb5-11e5-98c5-0002a5d5c51b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54766-799-045476607990428.4 g in 1 TUBE, WITH APPLICATOR (54766-799-04) 28.4 g2015-08-072026-07-31NoNoCurrent
54766-799-33547660799334 g in 1 TUBE, WITH APPLICATOR4 gHistorical
54766-799-36547660799364 g in 1 TUBE, WITH APPLICATOR4 gHistorical
54766-799-645476607996430 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-64) > 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) 2015-08-070000-00-00NoNoCurrent
54766-799-655476607996512 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-65) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) 2015-08-072026-11-30NoNoCurrent
54766-799-715476607997130 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-71) > 4 g in 1 TUBE, WITH APPLICATOR (54766-799-33) 2015-08-070000-00-00NoNoCurrent
54766-799-725476607997212 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-72) > 4 g in 1 TUBE, WITH APPLICATOR (54766-799-33) 2015-08-070000-00-00NoNoCurrent