FDA.reportPublic FDA data

NDC 60505-2806-07 - Carbamazepine

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
60505-2806
Requested NDC
60505-2806-07
Package NDCs from labels
60505-2806-3, 60505-2806-7, 60505-2806-8, 60505-2806-07
Manufacturer
Apotex Corp. | Apotex Inc.
Effective date
2026-09-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx onlyApotex Corp. | Apotex Inc.2026-09-10HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Major PharmaceuticalsMajor Pharmaceuticals2026-05-13HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - AvPAKAvPAK2026-01-08HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2025-11-05HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2025-07-28HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2025-05-12HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine - Bryant Ranch PrepackBryant Ranch Prepack2024-10-08HUMAN PRESCRIPTION DRUG LABEL
Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx onlyREMEDYREPACK INC.2023-03-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2806-3Carbamazepine30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3015
60505-2806-7Carbamazepine120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12015
60505-2806-8Carbamazepine1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2806CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]14Current NDC, Legacy NDC, 3 package rows20240922_e91f9de3-3fdd-0a6b-71ce-53a2cc142816.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2806-7EA - Each60505-280640e9f032-d2c1-4447-9b5f-6cfde4cdc9ac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
CARBAMAZEPINEACTIVE MOIETY33CM23913MCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
ETHYLCELLULOSE (7 MPA.S)INACTIVE INGREDIENTH3UP11403CCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
GELATININACTIVE INGREDIENT2G86QN327LCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARBAMAZEPINE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3

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 136 · 2,705 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
CarbamazepineCARBAMAZEPINEApotex Corp.e91f9de3-3fdd-0a6b-71ce-53a2cc1428162026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078986
ndc (package): 60505-2805-7
ndc (package): 60505-2807-3
ndc (package): 60505-2807-5
ndc (package): 60505-2807-7
ndc (package): 60505-2806-7
ndc (package): 60505-2805-8
ndc (package): 60505-2806-3
ndc (package): 60505-2806-8
ndc (package): 60505-2805-3
ndc (product): 60505-2807
ndc (product): 60505-2805
ndc (product): 60505-2806
ndc11 (package): 60505280607
rxcui: 200131
rxcui: 388311
rxcui: 200133
spl id: c24e1663-4df1-d5a1-f9ed-551ba3552575
spl set id: e91f9de3-3fdd-0a6b-71ce-53a2cc142816
unii: 33CM23913M
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
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
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
carbamazepineCARBAMAZEPINENorthstar Rx LLCc91a5a1b-5481-445b-86e8-f10109ac39372026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
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
CARBAMAZEPINECARBAMAZEPINEApotex Corp.bf0d012f-da14-8ce3-d74f-56172cddebc52026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
CarbamazepineCARBAMAZEPINEAmerican Health Packaging87b87b57-021a-4cb2-9edd-6efa732c208f2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 33CM23913M
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
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
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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