FDA.reportPublic FDA data

NDC 63629-1114-01 - 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
63629-1114
Requested NDC
63629-1114-01
Package NDCs from labels
63629-1114-1, 63629-1114-01
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
AMPHETAMINE SULFATE - Bryant Ranch PrepackBryant Ranch Prepack2024-01-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1114-1AMPHETAMINE SULFATE100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1114AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 1 package rows20240110_8f9341fc-4b95-4556-a51a-ea972fa6fccc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1114-1EA - Each63629-1114bc91c789-690f-49e2-948b-4bb518c630ed12020-09-14

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 2 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adderall XRDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATETakeda Pharmaceuticals America, Inc.aff45863-ffe1-4d4f-8acf-c7081512a6c02026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
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
unii: 6DPV8NK46S
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
unii: 6DPV8NK46S
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
unii: 6DPV8NK46S
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
unii: 6DPV8NK46S
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
unii: 6DPV8NK46S
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepackb94e2562-fd19-455f-ac10-2cc24302d27a2026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1600695
unii: 6DPV8NK46S
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepack920f99f4-ab78-4eed-9d80-08a2ebd0b7692026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 884655
unii: 6DPV8NK46S
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack9817a519-fdb0-474a-92f4-2e485c9cb0472026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1600695
unii: 6DPV8NK46S
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATEGLENMARK PHARMACEUTICALS INC., USA4564e404-8d71-4585-ab78-55857f4771432026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
Amphetamine SulfateAMPHETAMINE SULFATEEpic Pharma LLC432db708-91b7-4802-88c3-ceef597b91da2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1600695
rxcui: 884655
unii: 6DPV8NK46S
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEBurel Pharmaceuticals, LLCbcdd2fe2-d0de-4a28-aced-40ac9ce5122d2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATENorthStar RxLLC8468623b-9584-43ef-ac16-fc15b060624c2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATESpecGx LLC72ddd1c9-ddbd-4c95-acd9-003189a353a32025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
Amphetamine SulfateAMPHETAMINE SULFATEWilshire Pharmaceuticals, Inc.91add2e3-8359-47dc-b79f-197d36b028192025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1600695
rxcui: 884655
unii: 6DPV8NK46S
EvekeoAMPHETAMINE SULFATEAzurity Pharmaceuticals, Inc.f469fb38-0380-4621-9db3-a4f4291261562025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1600695
rxcui: 884655
unii: 6DPV8NK46S
Amphetamine SulfateAMPHETAMINEAmneal Pharmaceuticals NY LLC53d40847-e0d3-48ec-81a7-ec54785535652025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1600695
rxcui: 884655
unii: 6DPV8NK46S
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepack674940ec-1714-4e41-b471-2a8c8a6c5ade2025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 884655
unii: 6DPV8NK46S
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepackc972a6a4-a96c-4d70-b4c4-eef9e990abb42025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1600695
unii: 6DPV8NK46S
AMPHETAMINE SULFATEAMPHETAMINE SULFATESolco Healthcare US, LLC89c5b52f-3c2a-41d5-8624-9ee51c512c722025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211861
ndc (product): 43547-458
ndc (product): 43547-457
rxcui: 1600695
rxcui: 884655
spl id: b11d796e-584c-49a4-9f05-b499f5cd0f5e
spl set id: 89c5b52f-3c2a-41d5-8624-9ee51c512c72
unii: 6DPV8NK46S

Reported adverse events (FAERS/openFDA)#

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