Penicillamine

Product NDC
68475-201
11-digit product format
684750201
Labeler code
68475
Product ID
68475-201_0ee5ea02-a892-408f-aa5d-42ab034bdfc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillamine
Dosage form
CAPSULE
Route
ORAL
Labeler
Navinta LLC
Application
ANDA214363
Marketing category
ANDA
Marketing start
2022-01-01
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
4c108ea3-9ba7-fa75-c564-24ad70498a68Product name520220224
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
0e1adcb6-6a1d-c55b-4ff0-e09ab9548f27Product name320210602
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68475-201-01Penicillamine100 in 1 BOTTLECAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68475-201PENICILLAMINE CAPSULE [NAVINTA LLC]2Current NDC, Legacy NDC, 1 package rows20221213_064fb48d-aa34-4e52-9295-10f2ca4c77dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198070penicillAMINE 250 MG Oral CapsulePSN064fb48d-aa34-4e52-9295-10f2ca4c77dc2
198070penicillamine 250 MG Oral CapsuleSCD064fb48d-aa34-4e52-9295-10f2ca4c77dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68475-201-0168475020101100 CAPSULE in 1 BOTTLE (68475-201-01) 100 capsule2022-01-010000-00-00NoNoCurrent