FDA.reportPublic FDA data

CREXONT

Product NDC
64896-970
11-digit product format
648960970
Labeler code
64896
Product ID
64896-970_7ef8e64a-08b6-46d8-8b67-c8dfa7743ccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
NDA217186
Marketing category
NDA
Marketing start
2024-08-09
Substance
CARBIDOPA HYDRATE; LEVODOPA
Active strength
87.5; 350 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
CREXONT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA HYDRATE87.5 mg/1
LEVODOPA350 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64896-970-16CREXONT1 in 1 CARTONCAPSULE, EXTENDED RELEASE118
64896-970-16CREXONT120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12018
64896-970-23CREXONT120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12018
64896-970-23CREXONT1 in 1 CARTONCAPSULE, EXTENDED RELEASE118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64896-970CREXONT (CARBIDOPA AND LEVODOPA) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]14Current NDC, 4 package rows20250523_095a08b6-b0b8-4f88-b759-67e8b87287a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2690259carbidopa 35 MG / levodopa 140 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690279carbidopa 52.5 MG / levodopa 210 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690284carbidopa 70 MG / levodopa 280 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690290carbidopa 87.5 MG / levodopa 350 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690265CREXONT 35 MG / 140 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690281CREXONT 52.5 MG / 210 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690286CREXONT 70 MG / 280 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690292CREXONT 87.5 MG / 350 MG Extended Release Oral CapsulePSN095a08b6-b0b8-4f88-b759-67e8b87287a019
2690265carbidopa 35 MG / levodopa 140 MG Extended Release Oral Capsule [Crexont]SBD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690281carbidopa 52.5 MG / levodopa 210 MG Extended Release Oral Capsule [Crexont]SBD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690286carbidopa 70 MG / levodopa 280 MG Extended Release Oral Capsule [Crexont]SBD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690292carbidopa 87.5 MG / levodopa 350 MG Extended Release Oral Capsule [Crexont]SBD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690259carbidopa 35 MG / levodopa 140 MG Extended Release Oral CapsuleSCD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690279carbidopa 52.5 MG / levodopa 210 MG Extended Release Oral CapsuleSCD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690284carbidopa 70 MG / levodopa 280 MG Extended Release Oral CapsuleSCD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690290carbidopa 87.5 MG / levodopa 350 MG Extended Release Oral CapsuleSCD095a08b6-b0b8-4f88-b759-67e8b87287a019
2690259carbidopa 35 MG / L-DOPA 140 MG Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690265carbidopa 35 MG / L-DOPA 140 MG Extended Release Oral Capsule [Crexont]SY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690279carbidopa 52.5 MG / L-DOPA 210 MG Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690281carbidopa 52.5 MG / L-DOPA 210 MG Extended Release Oral Capsule [Crexont]SY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690284carbidopa 70 MG / L-DOPA 280 MG Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690286carbidopa 70 MG / L-DOPA 280 MG Extended Release Oral Capsule [Crexont]SY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690290carbidopa 87.5 MG / L-DOPA 350 MG Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690292carbidopa 87.5 MG / L-DOPA 350 MG Extended Release Oral Capsule [Crexont]SY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690265Crexont (carbidopa 35 MG / levodopa 140 MG) Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690281Crexont (carbidopa 52.5 MG / levodopa 210 MG) Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690286Crexont (carbidopa 70 MG / levodopa 280 MG) Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019
2690292Crexont (carbidopa 87.5 MG / levodopa 350 MG) Extended Release Oral CapsuleSY095a08b6-b0b8-4f88-b759-67e8b87287a019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64896-970-16648960970161 BOTTLE in 1 CARTON (64896-970-16) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-08-09NoNoCurrent
64896-970-23648960970231 BOTTLE in 1 CARTON (64896-970-23) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE1 bottle2024-08-09YesNoCurrent