FDA.reportPublic FDA data

NDC 63629-1978-01 - Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine 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
63629-1978
Requested NDC
63629-1978-01
Package NDCs from labels
63629-1978-1, 63629-1978-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMPHETAMINE SULFATE - Bryant Ranch PrepackBryant Ranch Prepack2024-08-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1978-1Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1978DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240901_718d954a-6bdc-4d2c-9824-324c4f9d13f6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1978-1EA - Each63629-1978fc2fac70-2eae-47e8-8c32-b44c6d2a981412021-06-02

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 11 of 107 · 2,123 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4a822-a7ab-b374-e063-6394a90a85082026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4d44e-3421-535f-e063-6294a90a2fea2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef5baf7-00b1-97aa-e063-6294a90aab9c2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef5dcd4-b2d0-bcd1-e063-6294a90a871f2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef6b5fb-5495-001c-e063-6394a90ab7b32026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc4ee39bbf-b7d7-8f87-e063-6294a90a25392026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Nu Colour Bioadaptive BB plus Foundation - BeigeTITANIUM DIOXIDENSE Products, Inc.f74e83fe-41a0-4998-ae53-30ed5af475922026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack109bf90d-7a0d-40b4-8672-03343723a6212026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205401
rxcui: 861225
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepackbdc60a48-859e-46d1-bd60-395a23aa55952026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205401
rxcui: 861232
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepackdff1a614-2b4b-4d09-804f-2f182ceec6b92026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205401
rxcui: 861221
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack23d5ce6b-7b59-402f-b32e-ed99231d9eb92026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205401
rxcui: 861237
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack2fa68671-d396-43cd-a9d0-907dc293c82f2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205401
rxcui: 861227
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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