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Medicines · US (FDA)

FDA 2025

Dopa and dopa derivatives

Carbidopa and Levodopa

Approved 13 Jun 2025Capsule, extended release

The FDA lists this product in 14 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: CARBIDOPA, LEVODOPA 48.75MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

CARBIDOPA, LEVODOPA 195MG · Capsule, extended releaseANDA219231-008 · Tentative approval
CARBIDOPA, LEVODOPA 61.25MG · Capsule, extended releaseANDA219231-006 · Tentative approval
CARBIDOPA, LEVODOPA 95MG · Capsule, extended releaseANDA219231-004 · Tentative approval
CARBIDOPA, LEVODOPA 145MG · Capsule, extended releaseANDA219231-002 · Tentative approval
CARBIDOPA, LEVODOPA 48.75MG · Capsule, extended releaseThis page
CARBIDOPA, LEVODOPA 245MG · Capsule, extended releaseANDA219231-005 · Tentative approval
CARBIDOPA, LEVODOPA 23.75 · Capsule, extended releaseANDA219231-003 · Tentative approval
CARBIDOPA, LEVODOPA 52.5MG · Capsule, extended releaseANDA219989-007 · Tentative approval
CARBIDOPA, LEVODOPA 70MG · Capsule, extended releaseANDA219989-005 · Tentative approval

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

CARBIDOPA, LEVODOPA 87.5MG · Capsule, extended releaseANDA219989-003 · Tentative approval

CARBIDOPA, LEVODOPA 210MG · Capsule, extended releaseANDA219989-008 · Tentative approval

CARBIDOPA, LEVODOPA 280MG · Capsule, extended releaseANDA219989-006 · Tentative approval

CARBIDOPA, LEVODOPA 350MG · Capsule, extended releaseANDA219989-004 · Tentative approval

CARBIDOPA, LEVODOPA 140MG · Capsule, extended releaseANDA219989-002 · Tentative approval

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA219231.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Carbidopa and Levodopa
Active substance: carbidopa, levodopa
Drug class: Dopa and dopa derivatives
Dosage form: Capsule, extended release
Applicant: DR Reddys Labs LTD
Status: Tentative approval
FDA approval: 13 Jun 2025
Application: ANDA219231-007
RxCUI: 103990