FDA.reportPublic FDA data

RYTARY

Product NDC
64896-661
11-digit product format
648960661
Labeler code
64896
Product ID
64896-661_ef3fe5ab-c753-409b-a5f3-b55e3eefd070
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbidopa and Levodopa
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
NDA203312
Marketing category
NDA
Marketing start
2015-01-12
Substance
CARBIDOPA HYDRATE; LEVODOPA
Active strength
23.75; 95 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RYTARY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA HYDRATE23.75 mg/1
LEVODOPA95 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii46627O600J, MNX7R8C5VO
Rxcui1600773, 1600774, 1600775, 1600776, 1600914, 1600915, 1600916, 1600917

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442Product name520251106
162160fe-5ea6-4f9d-aa38-c4b780c57046Product name120250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42Product name120250312
028fdaca-77da-0dfe-e445-7dfc440fc97eProduct name420250224
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name720241218
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64896-661-01RYTARY100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10026
64896-661-09RYTARY25 in 1 BOTTLECAPSULE, EXTENDED RELEASE2526
64896-661-43RYTARY240 in 1 BOTTLECAPSULE, EXTENDED RELEASE24026
64896-661-99RYTARY100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64896-661-01EA - Each64896-661ca9ec888-2117-4e01-bed4-0cd549069a8c12015-02-02
64896-661-09EA - Each64896-661609847b2-f79f-4e38-a6e9-96843e5ee11212019-03-12
64896-661-43EA - Each64896-661d569fe45-4d2e-4b0d-a4d8-e1244efb1e2612015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CarbidopaACTIVE INGREDIENTMNX7R8C5VORYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
LevodopaACTIVE INGREDIENT46627O600JRYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Carbidopa AnhydrousACTIVE MOIETYKR87B45RGHRYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
LevodopaACTIVE MOIETY46627O600JRYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61URYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BRYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Hypromellose 2910 (6 Mpa.S)INACTIVE INGREDIENT0WZ8WG20P6RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
MannitolINACTIVE INGREDIENT3OWL53L36ARYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)INACTIVE INGREDIENT74G4R6TH13RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)INACTIVE INGREDIENT5KY68S2577RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
PovidonesINACTIVE INGREDIENTFZ989GH94ERYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JRYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1URYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Tartaric AcidINACTIVE INGREDIENTW4888I119HRYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMRYTARY (LEVODOPA AND CARBIDOPA) CAPSULE, EXTENDED RELEASE RYTARY (LEVODOPA AND CARBIDOPA) CAPSULE [IMPAX LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64896-661RYTARY (CARBIDOPA AND LEVODOPA) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]22Current NDC, Legacy NDC, 4 package rows20241025_6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600773carbidopa 23.75 MG / levodopa 95 MG 8HR Extended Release Oral CapsulePSN6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600775carbidopa 36.25 MG / levodopa 145 MG 8HR Extended Release Oral CapsulePSN6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600914carbidopa 48.75 MG / levodopa 195 MG 8HR Extended Release Oral CapsulePSN6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600916carbidopa 61.25 MG / levodopa 245 MG 8HR Extended Release Oral CapsulePSN6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600774RYTARY 23.75 MG / 95 MG 8HR Extended Release Oral CapsulePSN6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600776RYTARY 36.25 MG /145 MG 8HR Extended Release Oral CapsulePSN6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600915RYTARY 48.75 MG / 195 MG 8HR Extended Release Oral CapsulePSN6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600917RYTARY 61.25 MG / 245 MG 8HR Extended Release Oral CapsulePSN6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16007748 HR carbidopa 23.75 MG / levodopa 95 MG Extended Release Oral Capsule [Rytary]SBD6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16007768 HR carbidopa 36.25 MG / levodopa 145 MG Extended Release Oral Capsule [Rytary]SBD6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16009158 HR carbidopa 48.75 MG / levodopa 195 MG Extended Release Oral Capsule [Rytary]SBD6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16009178 HR carbidopa 61.25 MG / levodopa 245 MG Extended Release Oral Capsule [Rytary]SBD6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16007738 HR carbidopa 23.75 MG / levodopa 95 MG Extended Release Oral CapsuleSCD6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16007758 HR carbidopa 36.25 MG / levodopa 145 MG Extended Release Oral CapsuleSCD6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16009148 HR carbidopa 48.75 MG / levodopa 195 MG Extended Release Oral CapsuleSCD6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16009168 HR carbidopa 61.25 MG / levodopa 245 MG Extended Release Oral CapsuleSCD6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16007738 HR Carbidopa 23.75 MG / L-DOPA 95 MG Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16007748 HR Carbidopa 23.75 MG / L-DOPA 95 MG Extended Release Oral Capsule [Rytary]SY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16007758 HR Carbidopa 36.25 MG / L-DOPA 145 MG Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16007768 HR Carbidopa 36.25 MG / L-DOPA 145 MG Extended Release Oral Capsule [Rytary]SY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16009148 HR Carbidopa 48.75 MG / L-DOPA 195 MG Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16009158 HR Carbidopa 48.75 MG / L-DOPA 195 MG Extended Release Oral Capsule [Rytary]SY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16009168 HR Carbidopa 61.25 MG / L-DOPA 245 MG Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
16009178 HR Carbidopa 61.25 MG / L-DOPA 245 MG Extended Release Oral Capsule [Rytary]SY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600773carbidopa 23.75 MG / levodopa 95 MG 8 HR Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600775carbidopa 36.25 MG / levodopa 145 MG 8 HR Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600914carbidopa 48.75 MG / levodopa 195 MG 8 HR Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600916carbidopa 61.25 MG / levodopa 245 MG 8 HR Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600774Rytary (carbidopa 23.75 MG / levodopa 95 MG) 8 HR Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600776Rytary (carbidopa 36.25 MG / levodopa 145 MG) 8 HR Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600915Rytary (carbidopa 48.75 MG / levodopa 195 MG) 8 HR Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726
1600917Rytary (carbidopa 61.25 MG / levodopa 245 MG) 8 HR Extended Release Oral CapsuleSY6c1f7cd4-de56-45c1-a734-5e77b4aeb6f726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64896-661-0164896066101100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-01) 2015-01-120000-00-00NoNoCurrent
64896-661-096489606610925 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-09) 2015-01-120000-00-00NoNoCurrent
64896-661-4364896066143240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-43) 2015-01-120000-00-00NoNoCurrent
64896-661-9964896066199100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64896-661-99) 2015-01-120000-00-00NoNoCurrent