FDA.reportPublic FDA data

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 116 of 122 · 2,424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
arthritis pain relieverDICLOFENAC SODIUMH E Be8fe4a89-586d-461c-b242-b68e38a508b42023-03-09WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMQuality Care Products LLC94422b85-28ed-477f-853a-71d1d6cf17d52023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
unii: 15FIX9V2JP
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LP73a46413-ecbc-4453-814d-bec955b375d22023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPb41335b6-859f-4568-84d2-0d0408415a4e2023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMCostco Wholesale141b6693-6d6c-45c6-9b82-ee1afcfca12a2023-01-27WarningsExact identifier
unii: QTG126297Q
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%Proficient Rx LPb4694451-a13d-484e-92c4-c03a6fcbb5112023-01-01WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium 1.5%DICLOFENAC SODIUM TOPICALProficient Rx LP90b25b9b-3930-48af-b139-d24f2fccfcdc2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMProficient Rx LPb98d921a-2ee7-4770-ac21-d845b2dcc11c2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMP & L Development, LLC2596645a-b736-4d3c-82a0-00713f1b6fbd2022-12-15WarningsExact identifier
unii: QTG126297Q
DiclofenacDICLOFENAC SODIUMAltaire Pharmaceuticals Inc.5372866a-dab3-45c8-8c2a-755ca36c17912022-10-28Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENACAsclemed USA, Inc.9df599de-6412-a94e-e053-2995a90a17412022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMAsclemed USA, Inc.d4b81a74-6926-4715-bf90-aec026cff2b42022-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.b162d65d-b105-4a68-90bb-316b9686267b2022-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMRite Aid Corporation1c9ea3b2-8f45-420b-87d3-dc7de0be2d5f2022-08-23WarningsExact identifier
unii: QTG126297Q
diclofenac sodiumDICLOFENAC SODIUMProficient Rx LP67e384c6-8476-4aad-b967-241335538d562022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMProficient Rx LPafce2de2-0c59-4191-bf79-782ca31e427d2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075185
rxcui: 855926
rxcui: 855906
unii: QTG126297Q
Diclofenac Sodium MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLProficient Rx LP33f7db0b-f049-4d2e-abf5-4db97222e1752022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions3a520306-fe3e-4830-963f-04b080db3abc2022-06-01Warnings, Adverse reactionsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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