FDA.reportPublic FDA data

Analpram HC

Product NDC
83107-019
11-digit product format
831070019
Labeler code
83107
Product ID
83107-019_4dcbb97c-b493-022f-e063-6294a90ac089
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone acetate and pramoxine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Legacy Pharma USA Inc.
Application
ANDA085979
Marketing category
ANDA
Marketing start
2025-07-25
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
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83107-019-01Analpram HC28 g in 1 TUBE, WITH APPLICATORCREAM282
83107-019-12Analpram HC12 in 1 CARTONCREAM122
83107-019-12Analpram HC4 g in 1 TUBE, WITH APPLICATORCREAM42
83107-019-30Analpram HC30 in 1 CARTONCREAM302
83107-019-30Analpram HC4 g in 1 TUBE, WITH APPLICATORCREAM42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83107-019-01GM - Gram83107-019d56a377c-f08e-44d5-bea4-2527aa106bce12025-10-14
83107-019-12GM - Gram83107-01905f54610-7ff3-4523-809b-0b988ffd5b3e12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362211Analpram 2.5 % / 1 % Rectal CreamPSN3e5c6728-ece3-40f7-9e36-cff71f168cd82
1294025hydrocortisone acetate 2.5 % / pramoxine HCl 1 % Rectal CreamPSN3e5c6728-ece3-40f7-9e36-cff71f168cd82
1362211hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream [Analpram HC]SBD3e5c6728-ece3-40f7-9e36-cff71f168cd82
1294025hydrocortisone acetate 25 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD3e5c6728-ece3-40f7-9e36-cff71f168cd82
1362211Analpram HC 2.5 % / 1 % (hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % ) Rectal CreamSY3e5c6728-ece3-40f7-9e36-cff71f168cd82
1294025hydrocortisone acetate 2.5 % / pramoxine hydrochloride 1 % Rectal CreamSY3e5c6728-ece3-40f7-9e36-cff71f168cd82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83107-019-018310700190128 g in 1 TUBE, WITH APPLICATOR28 gHistorical
83107-019-128310700191212 TUBE, WITH APPLICATOR in 1 CARTON (83107-019-12) / 4 g in 1 TUBE, WITH APPLICATOR2025-07-25NoNoHistorical
83107-019-308310700193030 TUBE, WITH APPLICATOR in 1 CARTON (83107-019-30) / 4 g in 1 TUBE, WITH APPLICATOR2025-07-25NoNoHistorical