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 5 of 159 · 3,174 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naltrexone HydrochlorideNALTREXONE HYDROCHLORIDERedpharm Drug57439bad-00f0-5696-e063-6294a90a2ea52026-07-23Warnings, Adverse reactionsExact identifier
unii: Z6375YW9SF
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENTAcella Pharmaceuticals, LLC038fe2e7-dc16-485c-b5fb-746db72313472026-07-23Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEBryant Ranch Prepackf9807ec0-3504-4c66-8efe-ea25f84c782b2026-07-15Warnings, Adverse reactionsExact identifier
unii: Z6375YW9SF
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Morphine sulfateMORPHINE SULFATEBryant Ranch Prepack595243fe-a4b1-479a-99d6-a084a41818912026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Morphine SulfateMORPHINE SULFATEHikma Pharmaceuticals USA Inc.6023606c-150c-40c5-9175-598efe2a56c32026-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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