FDA.reportPublic FDA data

NDC 65162-649-43 - Oxcarbazepine

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
65162-649
Requested NDC
65162-649-43
Package NDCs from labels
65162-649-78, 65162-649-43, 65162-649-48
Manufacturer
Bryant Ranch Prepack
Effective date
2026-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxcarbazepine - Bryant Ranch PrepackBryant Ranch Prepack2026-03-20HUMAN PRESCRIPTION DRUG LABEL
Oxcarbazepine - Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLCAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC2025-10-01HUMAN PRESCRIPTION DRUG LABEL
Oxcarbazepine - Precision Dose, Inc.Precision Dose, Inc.2023-11-20HUMAN PRESCRIPTION DRUG LABEL
Oxcarbazepine - AvPAKAvPAK2022-11-15HUMAN PRESCRIPTION DRUG LABEL
Oxcarbazepine - REMEDYREPACK INC.REMEDYREPACK INC.2022-04-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-649-43Oxcarbazepine5 mL in 1 CUP, UNIT-DOSESUSPENSION528
65162-649-48Oxcarbazepine10 in 1 TRAYSUSPENSION1028
65162-649-78Oxcarbazepine1 in 1 CARTONSUSPENSION128
65162-649-78Oxcarbazepine250 mL in 1 BOTTLESUSPENSION25028

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-649OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS LLC]27Current NDC, Legacy NDC, 4 package rows20250227_2515391e-3a88-4226-92e5-f641c8409fe5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-649-78ML - Milliliter65162-6491f057bcc-6f00-46a9-b8a1-aa70e9418d4712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
MALIC ACIDINACTIVE INGREDIENT817L1N4CKPOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
SORBITOLINACTIVE INGREDIENT506T60A25ROXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
WATERINACTIVE INGREDIENT059QF0KO0ROXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEOXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]14

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 51 · 1,007 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
OxcarbazepineOXCARBAZEPINEZameer Pharmaceuticals LLC8841174a-9f4b-424f-a50d-01478f2aeb292026-08-26Warnings, Adverse reactionsExact identifier
unii: VZI5B1W380
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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