Penicillamine

Product NDC
51991-974
11-digit product format
519910974
Labeler code
51991
Product ID
51991-974_704ba860-2350-4024-a2bb-fc379ea69218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillamine
Dosage form
CAPSULE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA215409
Marketing category
ANDA
Marketing start
2021-11-12
Substance
PENICILLAMINE
Active strength
250 mg/1
Pharmacologic classes
Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLAMINE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGNN1DV99GX
Rxcui198070

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
51991-974-01Penicillamine100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-974-01EA - Each51991-97468545ddc-2ba8-4319-8202-5f6db6ffe10712022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-974PENICILLAMINE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2Current NDC, Legacy NDC, 1 package rows20240327_1320f46b-e243-4e93-b9c9-ad8eb7828de5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198070penicillAMINE 250 MG Oral CapsulePSN1320f46b-e243-4e93-b9c9-ad8eb7828de52
198070penicillamine 250 MG Oral CapsuleSCD1320f46b-e243-4e93-b9c9-ad8eb7828de52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-974-0151991097401100 CAPSULE in 1 BOTTLE (51991-974-01) 100 capsule2021-11-120000-00-00NoNoCurrent