FDA.reportPublic FDA data

NDC 16729-079-16 - CARBIDOPA AND LEVODOPA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
16729-079
Requested NDC
16729-079-16
Package NDCs from labels
16729-079-10, 16729-079-01, 16729-079-16, 16729-079-17
Manufacturer
Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd
Effective date
2025-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CARBIDOPA AND LEVODOPA - Accord Healthcare, Inc. | Intas Pharmaceuticals LtdAccord Healthcare, Inc. | Intas Pharmaceuticals Ltd2025-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-079-01CARBIDOPA AND LEVODOPA100 in 1 BOTTLETABLET, EXTENDED RELEASE10011
16729-079-10CARBIDOPA AND LEVODOPA30 in 1 BOTTLETABLET, EXTENDED RELEASE3011
16729-079-16CARBIDOPA AND LEVODOPA500 in 1 BOTTLETABLET, EXTENDED RELEASE50011
16729-079-17CARBIDOPA AND LEVODOPA1000 in 1 BOTTLETABLET, EXTENDED RELEASE100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-079CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]10Current NDC, Legacy NDC, 4 package rows20240328_5217a6ec-cc26-4acc-b2da-17f6545c3b60.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-079-01EA - Each16729-07938737cc6-27d4-47d6-a2ed-03d2445e7c9612013-07-02
16729-079-17EA - Each16729-0793e9fe769-cfb6-40bd-af67-5484b72c167e12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBIDOPAACTIVE INGREDIENTMNX7R8C5VOCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
LEVODOPAACTIVE INGREDIENT46627O600JCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
CARBIDOPA ANHYDROUSACTIVE MOIETYKR87B45RGHCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
LEVODOPAACTIVE MOIETY46627O600JCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
HYPROMELLOSE 2208 (4000 MPA.S)INACTIVE INGREDIENT39J80LT57TCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE, INC.]6

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 5 of 38 · 755 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
CREXONTCARBIDOPA AND LEVODOPAAmneal Pharmaceuticals LLC095a08b6-b0b8-4f88-b759-67e8b87287a02026-05-29Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMajor Pharmaceuticals3f6d393e-ac84-4a3c-a837-199d1ec71fd22026-05-28Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAWestminster Pharmaceuticals, LLC3f026272-32a6-4c98-8b6f-d910c7f58aa22026-05-27Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
Carbidopa and LevodopaCARBIDOPA AND LEVODOPADr. Reddy's Laboratories Inc87ab55c9-203d-d595-3e3e-0e38f2f6d9c42026-05-19Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
Carbidopa and levodopaCARBIDOPA AND LEVODOPAAdvagen Pharma Ltd5b6519ff-d1af-402b-83eb-b4fce6743a182026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 308988
rxcui: 308989
unii: MNX7R8C5VO
unii: 46627O600J
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
unii: 1K09F3G675
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.4ce99f65-5857-448c-b22a-9b3b64de69e22026-04-29Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAScieGen Pharmaceuticals Inca32afa84-7bc0-4bd3-bc50-55d738f3d7ce2026-04-27Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAMylan Pharmaceuticals Inc.aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 308988
rxcui: 308989
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAREMEDYREPACK INC.b29e58f0-67b1-4036-a4a8-4915a8c13cdf2026-04-24Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.