FDA.reportPublic FDA data

NDC 72162-1369-01 - 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
72162-1369
Requested NDC
72162-1369-01
Package NDCs from labels
72162-1369-1, 72162-1369-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-01-25
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 Prepack2024-01-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1369-1AMPHETAMINE SULFATE100 in 1 BOTTLETABLET100100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1369AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240126_7f16dd18-bf30-41ef-8981-932da5df0951.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1369-1EA - Each72162-1369c996b896-ca63-4b82-8774-8ea712459b8d12024-03-12

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
ndc (package): 72162-1369-1
ndc (product): 72162-1369
ndc11 (package): 72162136901
rxcui: 1600695
spl id: b7799b14-8dd8-472b-8279-5f6ba27aa313
spl set id: 7f16dd18-bf30-41ef-8981-932da5df0951
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
rxcui: 1600695
rxcui: 884655
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.