Home NDC 62332-796-31 carbidopa, levodopa and entacapone
Product NDC 62332-796
Requested package NDC 62332-796-31
11-digit product format 623320796
Labeler code 62332
Product ID 62332-796_ec2d4d50-cf4e-48fe-abee-391925e18c3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carbidopa, levodopa and entacapone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA218535
Marketing category ANDA
Marketing start 2026-02-12
Substance CARBIDOPA; ENTACAPONE; LEVODOPA
Active strength 18.75; 200; 75 mg/1; mg/1; mg/1
Pharmacologic classes Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218535-001 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 12.5MG;200MG;50MG TABLET / ORAL AB 2026-02-05 A218535-002 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 18.75MG;200MG;75MG TABLET / ORAL AB 2026-02-05 A218535-003 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 25MG;200MG;100MG TABLET / ORAL AB 2026-02-05 A218535-004 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 31.25MG;200MG;125MG TABLET / ORAL AB 2026-02-05 A218535-005 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 37.5MG;200MG;150MG TABLET / ORAL AB 2026-02-05 A218535-006 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 50MG;200MG;200MG TABLET / ORAL AB 2026-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218535-001 CARBIDOPA, LEVODOPA AND ENTACAPONE 12.5MG;200MG;50MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218535-002 CARBIDOPA, LEVODOPA AND ENTACAPONE 18.75MG;200MG;75MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218535-003 CARBIDOPA, LEVODOPA AND ENTACAPONE 25MG;200MG;100MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218535-004 CARBIDOPA, LEVODOPA AND ENTACAPONE 31.25MG;200MG;125MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218535-005 CARBIDOPA, LEVODOPA AND ENTACAPONE 37.5MG;200MG;150MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218535-006 CARBIDOPA, LEVODOPA AND ENTACAPONE 50MG;200MG;200MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218535-001 CARBIDOPA, LEVODOPA AND ENTACAPONE 12.5MG;200MG;50MG TABLET / ORAL AB 2026-02-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218535-002 CARBIDOPA, LEVODOPA AND ENTACAPONE 18.75MG;200MG;75MG TABLET / ORAL AB 2026-02-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218535-003 CARBIDOPA, LEVODOPA AND ENTACAPONE 25MG;200MG;100MG TABLET / ORAL AB 2026-02-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218535-004 CARBIDOPA, LEVODOPA AND ENTACAPONE 31.25MG;200MG;125MG TABLET / ORAL AB 2026-02-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218535-005 CARBIDOPA, LEVODOPA AND ENTACAPONE 37.5MG;200MG;150MG TABLET / ORAL AB 2026-02-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218535-006 CARBIDOPA, LEVODOPA AND ENTACAPONE 50MG;200MG;200MG TABLET / ORAL AB 2026-02-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base carbidopa, levodopa and entacapone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBIDOPA 18.75 mg/1 LEVODOPA 200 mg/1 ENTACAPONE 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4975G9NM6T Internal UNII lookup MNX7R8C5VO Internal UNII lookup 46627O600J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403850 Internal RxNorm lookup 403851 Internal RxNorm lookup 403852 Internal RxNorm lookup 730988 Internal RxNorm lookup 810083 Internal RxNorm lookup 810090 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62332-796-31 carbidopa, levodopa and entacapone 100 in 1 BOTTLE TABLET, FILM COATED 100 4 62332-796-91 carbidopa, levodopa and entacapone 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62332-796-31 62332079631 100 TABLET, FILM COATED in 1 BOTTLE (62332-796-31) 2026-02-12 No No Current