Depen

Product NDC
0037-4401
11-digit product format
000374401
Labeler code
0037
Product ID
0037-4401_d5cb9986-f53c-4f8c-acb9-d5bdff6f07b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillamine
Dosage form
TABLET
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA019854
Marketing category
NDA
Marketing start
1978-11-30
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
Depen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLAMINE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGNN1DV99GX
Rxcui198071, 207370

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
0037-4401-01Depen100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-4401-01EA - Each0037-440119e2faf3-7bfa-4d0a-a398-414d5bf19b8812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENICILLAMINEACTIVE INGREDIENTGNN1DV99GXDEPEN (PENICILLAMINE) TABLET [MEDA PHARMACEUTICALS INC.]2
PENICILLAMINEACTIVE MOIETYGNN1DV99GXDEPEN (PENICILLAMINE) TABLET [MEDA PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0037-4401DEPEN (PENICILLAMINE) TABLET [MEDA PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 1 package rows20231102_38f8ae60-b354-11de-8a39-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207370Depen Titratable Tablets 250 MG Oral TabletPSN38f8ae60-b354-11de-8a39-0800200c9a668
198071penicillAMINE 250 MG Oral TabletPSN38f8ae60-b354-11de-8a39-0800200c9a668
207370penicillamine 250 MG Oral Tablet [Depen]SBD38f8ae60-b354-11de-8a39-0800200c9a668
198071penicillamine 250 MG Oral TabletSCD38f8ae60-b354-11de-8a39-0800200c9a668
207370Depen 250 MG Oral TabletSY38f8ae60-b354-11de-8a39-0800200c9a668

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0037-4401-0100037440101100 TABLET in 1 BOTTLE (0037-4401-01) 100 tablet1978-11-300000-00-00NoNoCurrent