rytary

Generic: carbidopa and levodopa

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rytary
Generic Name carbidopa and levodopa
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbidopa hydrate 23.75 mg/1, levodopa 95 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 64896-661
Product ID 64896-661_b09ad6a1-03e2-4c81-8c37-354d2f3ccf13
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203312
Listing Expiration 2026-12-31
Marketing Start 2015-01-12

Pharmacologic Class

Established (EPC)
aromatic amino acid [epc]
Chemical Structure
amino acids, aromatic [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64896661
Hyphenated Format 64896-661

Supplemental Identifiers

RxCUI
1600773 1600774 1600775 1600776 1600914 1600915 1600916 1600917
UPC
0364896663016 0364896664013 0364896662019 0364896661012
UNII
46627O600J MNX7R8C5VO
NUI
N0000193220 M0370111

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 rytary (source: ndc)
Generic Name carbidopa and levodopa (source: ndc)
Application Number NDA203312 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 23.75 mg/1
  • 95 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-01)
  • 25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-09)
  • 240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-43)
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-99)
source: ndc

Packages (4)

64896-661-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-01) 64896-661-09 25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-09) 64896-661-43 240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-43) 64896-661-99 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-99)

Ingredients (2)

carbidopa hydrate (23.75 mg/1) levodopa (95 mg/1)

Linked Drug Pages (1)

RYTARY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b09ad6a1-03e2-4c81-8c37-354d2f3ccf13", "openfda": {"nui": ["N0000193220", "M0370111"], "upc": ["0364896663016", "0364896664013", "0364896662019", "0364896661012"], "unii": ["46627O600J", "MNX7R8C5VO"], "rxcui": ["1600773", "1600774", "1600775", "1600776", "1600914", "1600915", "1600916", "1600917"], "spl_set_id": ["6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7"], "pharm_class_cs": ["Amino Acids, Aromatic [CS]"], "pharm_class_epc": ["Aromatic Amino Acid [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-01)", "package_ndc": "64896-661-01", "marketing_start_date": "20150112"}, {"sample": false, "description": "25 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-09)", "package_ndc": "64896-661-09", "marketing_start_date": "20150112"}, {"sample": false, "description": "240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-43)", "package_ndc": "64896-661-43", "marketing_start_date": "20150112"}, {"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-99)", "package_ndc": "64896-661-99", "marketing_start_date": "20150112"}], "brand_name": "RYTARY", "product_id": "64896-661_b09ad6a1-03e2-4c81-8c37-354d2f3ccf13", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Amino Acids", "Aromatic [CS]", "Aromatic Amino Acid [EPC]"], "product_ndc": "64896-661", "generic_name": "Carbidopa and Levodopa", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RYTARY", "active_ingredients": [{"name": "CARBIDOPA HYDRATE", "strength": "23.75 mg/1"}, {"name": "LEVODOPA", "strength": "95 mg/1"}], "application_number": "NDA203312", "marketing_category": "NDA", "marketing_start_date": "20150112", "listing_expiration_date": "20261231"}