FDA.reportPublic FDA data

NDC 63629-4484-09 - Morphine Sulfate

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
63629-4484
Requested NDC
63629-4484-09
Package NDCs from labels
63629-4484-1, 63629-4484-2, 63629-4484-3, 63629-4484-4, 63629-4484-5, 63629-4484-6, 63629-4484-7, 63629-4484-8, 63629-4484-9, 63629-4484-0, 63629-4484-09
Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Morphine Sulfate - Bryant Ranch PrepackBryant Ranch Prepack2026-04-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-4484-12020-10-12These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-22020-10-12These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-32020-10-12These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-42020-10-12These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-52020-10-12These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-62020-10-12These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-72020-10-12These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-82020-10-12These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-12020-01-31These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-22020-01-31These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-32020-01-31These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-42020-01-31These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-52020-01-31These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-62020-01-31These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-72020-01-31These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941
63629-4484-82020-01-31These highlights do not include all the information needed to use morphine sulfate extended-release tablets safely and effectively. See full prescribing information for morphine sulfate extended-release tablets. MORPHINE sulfate extended-release tablets for oral use, CII Initial U.S. Approval: 1941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4484-0Morphine Sulfate40 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE401012
63629-4484-1Morphine Sulfate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301012
63629-4484-2Morphine Sulfate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601012
63629-4484-3Morphine Sulfate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901012
63629-4484-4Morphine Sulfate120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1201012
63629-4484-5Morphine Sulfate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001012
63629-4484-6Morphine Sulfate5 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE51012
63629-4484-7Morphine Sulfate15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE151012
63629-4484-8Morphine Sulfate20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE201012
63629-4484-9Morphine Sulfate26 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE261012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4484MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1011Current NDC, Legacy NDC, 10 package rows20240524_cc3b491c-a206-3027-54f0-f87c0dd40a7f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4484-1EA - Each63629-4484cee03460-0076-4c1a-bd35-8515ac680eb712015-10-02
63629-4484-2EA - Each63629-4484d8ea9c5e-d47a-499f-bc2e-4a129a598f4a12015-10-02
63629-4484-3EA - Each63629-44848ea00261-35a0-4c85-ae01-5f99649edb2712012-07-24
63629-4484-4EA - Each63629-4484437d8f80-835d-4d72-87e4-501e2e429bd612013-02-13
63629-4484-5EA - Each63629-44844f1e2509-8b34-4948-a14c-b85eca4eae2312015-10-02
63629-4484-6EA - Each63629-4484e94a2324-4164-4980-9572-c3292b64ff6612015-10-02
63629-4484-7EA - Each63629-4484b5f5c428-68c0-4b75-9b20-f44f41db6a7f12025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]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 107 · 2,131 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.