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 4 of 4 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack00a0961d-b9f8-4be5-8ebf-9bd024cbe0292024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepack4804f3e0-2663-44f0-a10e-0baa56df9d692024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepackad4ce013-331b-4359-898f-bac97d64874f2024-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211861
rxcui: 884655
unii: 6DPV8NK46S
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack7f16dd18-bf30-41ef-8981-932da5df09512024-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211861
rxcui: 1600695
unii: 6DPV8NK46S
AMPHETAMINE SULFATEAMPHETAMINE SULFATELannett Company, Inc.85a015a7-a1a0-4b04-8bc4-7aacd0c847422024-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1600695
rxcui: 884655
unii: 6DPV8NK46S
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATENorthstar Rx LLCfacdf159-1d95-4981-a8ad-d82edcc14a0c2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack8f9341fc-4b95-4556-a51a-ea972fa6fccc2024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211861
ndc (package): 63629-1115-1
ndc (package): 63629-1114-1
ndc (product): 63629-1115
ndc (product): 63629-1114
ndc11 (package): 63629111401
rxcui: 1600695
rxcui: 884655
spl id: 4d1b4976-f17c-402e-bd3a-c49e320572b2
spl set id: 8f9341fc-4b95-4556-a51a-ea972fa6fccc
unii: 6DPV8NK46S
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEEpic Pharma, LLC1757e132-061d-4773-89ed-fdc77f69008f2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATESandoz Inc6f637e8d-7c2e-47fa-a43c-3250c51aed772023-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEPrasco Laboratoriesf85af6ee-9029-42de-adea-6dbb8642952c2023-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
Mixed Salts of a Single-Entity Amphetamine ProductDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATESpecGx LLCe1b21fd4-8d0b-4e54-a35d-8ad84a7caa782023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATECamber Pharmaceuticals, Inc.430cccec-1679-4225-8c86-92d746153b382023-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 4ELV7Z65AP
Amphetamine sulfateAMPHETAMINE SULFATE TABLETSDR. REDDY'S LABORATORIES INC79b9db39-7cdc-5607-f0ce-ac2a2cfd59d52023-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1600695
rxcui: 884655
unii: 6DPV8NK46S
Amphetamine SulfateAMPHETAMINE SULFATESpecGx LLC00242264-40d8-4267-a91a-727a1f0886162023-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1600695
rxcui: 884655
unii: 6DPV8NK46S

Reported adverse events (FAERS/openFDA)#

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