NDC 68084-158-11 - Morphine Sulfate Extended Release

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
68084-158
Requested NDC
68084-158-11
Package NDCs from labels
68084-158-11, 68084-158-01
Manufacturer
American Health Packaging
Effective date
2024-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Morphine Sulfate Extended Release - American Health PackagingAmerican Health Packaging2024-12-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-158-01Morphine SulfateExtended Release100 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE10012
68084-158-11Morphine SulfateExtended Release1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-158MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]12Current NDC, Legacy NDC, 2 package rows20250104_f915420d-981d-455b-b4cf-67c8e201a136.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-158-01EA - Each68084-158825048ba-1c20-4490-8633-c577cc39bad612013-10-17
68084-158-11EA - Each68084-1585947b2e2-7320-460d-b962-b2c486d3450912013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]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 1 of 108 · 2,143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Morphine SulfateMORPHINE SULFATEFresenius Kabi, USA LLC1f53de80-efc8-4930-b3e3-fba0d026af052026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MORPHINE SULFATEMORPHINE SULFATESpecGx LLC533034fd-c8e7-495b-8874-0db41bd1e65a2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 892646
rxcui: 891881
rxcui: 891888
rxcui: 891874
rxcui: 891893
unii: X3P646A2J0
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.67f0ee8d-696e-4c08-9007-3df0e3988bad2026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
Morphine SulfateMORPHINE SULFATEPrecision Dose, Inc.ae57637e-a86a-4ea5-9c68-47d98153d41a2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
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
Morphine SulfateMORPHINE SULFATEHikma Pharmaceuticals USA Inc.69a0d5be-3211-4b7f-962b-e9d9a507321f2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: X3P646A2J0
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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