FDA.reportPublic FDA data

NDC 72162-2049-03 - Dextroamphetamine Saccharate, Amphetamine Aspartate, 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
72162-2049
Requested NDC
72162-2049-03
Package NDCs from labels
72162-2049-1, 72162-2049-3, 72162-2049-6, 72162-2049-9, 72162-2049-03
Manufacturer
Bryant Ranch Prepack
Effective date
2023-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DEXTROAMPHETAMINE SACCHARATE - Bryant Ranch PrepackBryant Ranch Prepack2023-07-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2049-1Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate100 in 1 BOTTLETABLET100101
72162-2049-3Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate30 in 1 BOTTLETABLET30101
72162-2049-6Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate60 in 1 BOTTLETABLET60101
72162-2049-9Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate90 in 1 BOTTLETABLET90101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2049DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK]101Current NDC, 4 package rows20230715_095f7c39-2685-483a-9d90-47a1398b9dc9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2049-1EA - Each72162-2049d2f10979-a3d2-4a6c-9cdc-7e9bd8704bd012023-08-08
72162-2049-3EA - Each72162-20493fe3c076-f8c5-4721-be47-c16b552ccb2612023-08-08
72162-2049-6EA - Each72162-204974dd8881-ac4c-474d-9717-eeefab1631e512023-08-08
72162-2049-9EA - Each72162-2049cfeb5b3c-b27b-49aa-b875-119ee072059612023-08-08

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 9 · 172 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amphetamine SulfateAMPHETAMINE SULFATEAmici Pharma, Inc.e045dc28-e05d-4407-9d44-d0a11ca558e62026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEGranules Pharmaceuticals Inc.b0b4eccc-34c7-483d-966f-82d588358e1b2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 687043
rxcui: 1009145
rxcui: 541892
rxcui: 577957
rxcui: 541363
rxcui: 541878
rxcui: 577961
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Amphetamine SulfateAMPHETAMINE SULFATEGranules Pharmaceuticals Inc.26dbad66-13c4-4906-88b3-ab7ee191466c2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6DPV8NK46S
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEElite Laboratories, Inc.e677690f-790f-4626-ad78-097cdb6ea5402026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211352
ndc (product): 64850-501
rxcui: 687043
rxcui: 1009145
rxcui: 541892
rxcui: 577957
rxcui: 541363
rxcui: 541878
rxcui: 577961
spl id: a41cf8e5-cb1b-488c-96b3-3bef8283d6c4
spl set id: e677690f-790f-4626-ad78-097cdb6ea540
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEElite Laboratories, Inc.084c625c-94c6-4c8a-ba5f-6e26206dd9032026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
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 SULFATETeva Pharmaceuticals, Inc.5e84ef60-3050-40d9-9f14-66b85d289e172026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATEBryant Ranch Prepackff1e5518-0aa6-4bc9-bc87-8a6a124bc95a2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 541363
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATEGolden State Medical Supply, Inc.f6dfefdf-7a4a-e104-e053-6394a90a05bd2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
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 SULFATEANI Pharmaceuticals, Inc.6438480f-1147-42b6-826d-4e1e1f8ff0072026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
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 SULFATERhodes Pharmaceuticals LLCef3590cc-49ae-44f7-85a9-7c11f58d467e2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 687043
rxcui: 1009145
rxcui: 541892
rxcui: 577957
rxcui: 541363
rxcui: 541878
rxcui: 577961
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 SULFATEGranules Pharmaceuticals Inc.8c672e06-0778-4a7d-b398-5bcbf2a73f122026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-ReleaseDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATERhodes Pharmaceuticals LLC690e1ef4-caf7-4c48-a4ae-d2a0ab684e822026-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
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 SULFATEAmneal Pharmaceuticals of New York LLC89c4b21a-1a65-41ef-8718-1619c2ba85912026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATELannett Company, Inc.e95bdaf9-007a-4088-b969-fee38a97a4752026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATEActavis Pharma, Inc.c5c2d060-452c-4f76-ad93-2e41fd8f06c22026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
MYDAYISDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AND AMPHETAMINE SULFATETakeda Pharmaceuticals America, Inc.141a7970-3f06-44ea-9ab7-aeece2c085fc2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
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: JJ768O327N
unii: O1ZPV620O4
unii: 6DPV8NK46S
unii: G83415V073
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ