FDA.reportPublic FDA data

NDC 60793-433-01 - EMBEDA

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
60793-433
Requested NDC
60793-433-01
Package NDCs from labels
60793-433-20, 60793-433-01
Manufacturer
Pfizer Laboratories Div Pfizer Inc
Effective date
2019-10-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EMBEDA - Pfizer Laboratories Div Pfizer IncPfizer Laboratories Div Pfizer Inc2019-10-15HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60793-433-01EA - Each60793-433c7bf8cfe-2519-4012-af55-c12dfc8fee2e12012-07-24
60793-433-20EA - Each60793-43318a9a4d2-16b1-4310-a198-c3ac9b51f77212015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0EMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
NALTREXONE HYDROCHLORIDEACTIVE INGREDIENTZ6375YW9SFEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
MORPHINEACTIVE MOIETY76I7G6D29CEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
NALTREXONEACTIVE MOIETY5S6W795CQMEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0REMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8EMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
GELATININACTIVE INGREDIENT2G86QN327LEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
TALCINACTIVE INGREDIENT7SEV7J4R1UEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEMBEDA (MORPHINE SULFATE AND NALTREXONE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]12

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 2 of 159 · 3,174 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: 451W47IQ8X
unii: PQ6CK8PD0R
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.ae57637e-a86a-4ea5-9c68-47d98153d41a2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Mirexa MiniMIREXA MINIOncora Pharma, LLCea48f64a-9a70-40df-ba25-0983532730892026-08-25Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.76966c05-df75-4072-ae99-97e42f91ab752026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
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: 451W47IQ8X
Morphine SulfateMORPHINE SULFATEHikma Pharmaceuticals USA Inc.69a0d5be-3211-4b7f-962b-e9d9a507321f2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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