penicillamine

Generic: penicillamine

Labeler: navinta llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name penicillamine
Generic Name penicillamine
Labeler navinta llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

penicillamine 250 mg/1

Manufacturer
Navinta LLC

Identifiers & Regulatory

Product NDC 68475-201
Product ID 68475-201_0ee5ea02-a892-408f-aa5d-42ab034bdfc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214363
Listing Expiration 2026-12-31
Marketing Start 2022-01-01

Pharmacologic Class

Established (EPC)
antirheumatic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68475201
Hyphenated Format 68475-201

Supplemental Identifiers

RxCUI
198070
UNII
GNN1DV99GX
NUI
N0000175713

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name penicillamine (source: ndc)
Generic Name penicillamine (source: ndc)
Application Number ANDA214363 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68475-201-01)
source: ndc

Packages (1)

68475-201-01 100 CAPSULE in 1 BOTTLE (68475-201-01)

Ingredients (1)

penicillamine (250 mg/1)

Linked Drug Pages (1)

Penicillamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0ee5ea02-a892-408f-aa5d-42ab034bdfc4", "openfda": {"nui": ["N0000175713"], "unii": ["GNN1DV99GX"], "rxcui": ["198070"], "spl_set_id": ["064fb48d-aa34-4e52-9295-10f2ca4c77dc"], "pharm_class_epc": ["Antirheumatic Agent [EPC]"], "manufacturer_name": ["Navinta LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68475-201-01)", "package_ndc": "68475-201-01", "marketing_start_date": "20220101"}], "brand_name": "Penicillamine", "product_id": "68475-201_0ee5ea02-a892-408f-aa5d-42ab034bdfc4", "dosage_form": "CAPSULE", "pharm_class": ["Antirheumatic Agent [EPC]"], "product_ndc": "68475-201", "generic_name": "Penicillamine", "labeler_name": "Navinta LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Penicillamine", "active_ingredients": [{"name": "PENICILLAMINE", "strength": "250 mg/1"}], "application_number": "ANDA214363", "marketing_category": "ANDA", "marketing_start_date": "20220101", "listing_expiration_date": "20261231"}