Cuprimine

Product NDC
25010-705
11-digit product format
250100705
Labeler code
25010
Product ID
25010-705_08d38e76-baa2-473a-9b7c-18a4d9b96f9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillamine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bausch Health US, LLC
Application
NDA019853
Marketing category
NDA
Marketing start
1970-12-04
Substance
PENICILLAMINE
Active strength
250 mg/1
Pharmacologic classes
Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLAMINE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGNN1DV99GX
Rxcui198070, 207369

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4c108ea3-9ba7-fa75-c564-24ad70498a68Product name520220224
0e1adcb6-6a1d-c55b-4ff0-e09ab9548f27Product name320210602

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25010-705-15Cuprimine100 in 1 BOTTLECAPSULE10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25010-705-15EA - Each25010-705f33177be-6eff-40a9-9815-f62b5385c56712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PenicillamineACTIVE INGREDIENTGNN1DV99GXCUPRIMINE (PENICILLAMINE) CAPSULE [ATON PHARMA, INC.]2
PenicillamineACTIVE MOIETYGNN1DV99GXCUPRIMINE (PENICILLAMINE) CAPSULE [ATON PHARMA, INC.]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCUPRIMINE (PENICILLAMINE) CAPSULE [ATON PHARMA, INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LCUPRIMINE (PENICILLAMINE) CAPSULE [ATON PHARMA, INC.]2
lactoseINACTIVE INGREDIENTJ2B2A4N98GCUPRIMINE (PENICILLAMINE) CAPSULE [ATON PHARMA, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CUPRIMINE (PENICILLAMINE) CAPSULE [ATON PHARMA, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCUPRIMINE (PENICILLAMINE) CAPSULE [ATON PHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25010-705CUPRIMINE (PENICILLAMINE) CAPSULE [BAUSCH HEALTH US, LLC]10Current NDC, Legacy NDC, 1 package rows20210112_80e736d3-2017-4d68-94b4-38255c3c59c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207369Cuprimine 250 MG Oral CapsulePSN80e736d3-2017-4d68-94b4-38255c3c59c617
198070penicillAMINE 250 MG Oral CapsulePSN80e736d3-2017-4d68-94b4-38255c3c59c617
207369penicillamine 250 MG Oral Capsule [Cuprimine]SBD80e736d3-2017-4d68-94b4-38255c3c59c617
198070penicillamine 250 MG Oral CapsuleSCD80e736d3-2017-4d68-94b4-38255c3c59c617
207369Cuprimine 250 MG Oral CapsuleSY80e736d3-2017-4d68-94b4-38255c3c59c617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25010-705-1525010070515100 CAPSULE in 1 BOTTLE (25010-705-15) 100 capsule1970-12-040000-00-00NoNoCurrent