NDC 63629-2011-01 - Diclofenac Sodium Delayed 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
63629-2011
Requested NDC
63629-2011-01
Package NDCs from labels
63629-2011-1, 63629-2011-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-01-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Sodium Delayed Release - Bryant Ranch PrepackBryant Ranch Prepack2024-01-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2011-1Diclofenac Sodium Delayed Release500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE500102
63629-2011-1Diclofenac Sodium Delayed Release12 in 1 BOXTABLET, DELAYED RELEASE12102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2011DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240110_7c3d8d33-8849-44df-bb57-57d32b96a0e4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2011-1EA - Each63629-20116d12553e-db1f-4776-b8e0-8b9370644b8c12021-07-15

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 83 of 123 · 2,454 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium DRDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCd424ab84-2aaa-38a9-e053-2a95a90adde92024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac Sodium DRDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCec06cca5-3436-10c8-e053-2995a90a4aeb2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855906
unii: QTG126297Q
Diclofenac Sodium ERDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCecaa39b8-067c-80d7-e053-2a95a90a73542024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7267-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1896c84-b18a-d49d-e053-2995a90aaab32024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7264-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf3d27ae6-1259-5375-e053-2995a90a572d2024-12-31WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf187ae44-71be-a682-e053-2995a90a64262024-12-31Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACAdvanced Rx Pharmacy of Tennessee, LLCfc100cb2-16d9-f67d-e053-6294a90a0f2e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALAdvanced Rx Pharmacy of Tennessee, LLCfc0e6a51-bec3-f7ee-e053-6394a90ada9a2024-12-31Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCfc0e1950-d76f-75bc-e053-6294a90a8c122024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium DRDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCaf8a1392-67e8-8201-e053-2a95a90a0fce2024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc3a6db7d3-6c59-4633-a97e-1c03127246d32024-12-30WarningsExact identifier
unii: 15FIX9V2JP
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc87496037-36ca-4c5f-973f-46626cf4096e2024-12-27WarningsExact identifier
unii: 15FIX9V2JP
RODAN and FIELDS UNBLEMISHTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC2b3b6b62-364f-4aba-8024-3a73752b4c562024-12-27WarningsExact identifier
unii: 15FIX9V2JP
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, CORPORATION0d489154-6168-977e-e063-6394a90aa6092024-12-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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