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 3 of 38 · 755 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Carbidopa and LevodopaCARBIDOPA AND LEVODOPABryant Ranch Prepack3b06a0e2-bec8-4178-942b-67eb47f2916e2026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 308989
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPABryant Ranch Prepack043e58c6-092d-4637-90f1-9d36af143a242026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 308988
unii: MNX7R8C5VO
unii: 46627O600J
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Carbidopa and LevodopaCARBIDOPA AND LEVODOPACoupler LLC5682a705-de0e-6b70-e063-6394a90aadfb2026-07-13Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
CARBIDOPA AND LEVODOPACARBIDOPA AND LEVODOPAAphena Pharma Solutions - Tennessee, LLC5644d10f-620e-810e-e063-6294a90af6782026-07-10Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Carbidopa and levodopaCARBIDOPA AND LEVODOPATeva Pharmaceuticals USA, Inc.4ace5274-b6cf-414c-b9c0-f60e28a9cea52026-07-09Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
Carbidopa and LevodopaCARBIDOPA AND LEVODOPAAvPAK54f30abc-97fa-00f0-e063-6394a90a155d2026-06-23Warnings, Adverse reactionsExact identifier
unii: MNX7R8C5VO
unii: 46627O600J
Carbidopa and LevodopaCARBIDOPA AND LEVODOPARadha Pharmaceuticals Inc33a22ffe-0d41-162d-e063-6394a90a43d32026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 308988
rxcui: 308989
unii: MNX7R8C5VO
unii: 46627O600J
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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