Amphetamine Sulfate

Product NDC
69452-228
11-digit product format
694520228
Labeler code
69452
Product ID
69452-228_9845d365-ee3e-5db9-e053-2a95a90a81db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA212919
Marketing category
ANDA
Marketing start
2020-01-15
Marketing end
0000-00-00
Substance
AMPHETAMINE SULFATE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
8b92ab59-8b26-4c89-a2d6-8d5140526ec6Product name320231213
4496d022-9224-4ee0-943a-50fbe6cd7123Product name220220901
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
93730fbf-8b45-4623-b27d-cf03825d04b3Product name520220314
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69452-228-202025-01-30C16284748780-12cef2736-9fa4-d83d-e063-dadaa90ab31fAmphetamine Sulfate Tablets CII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-228-20Amphetamine Sulfate100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-228-20EA - Each69452-228e1bf5f18-f277-48b7-b3ef-bb2a99db81e512020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-228AMPHETAMINE SULFATE (AMPHETAMINE) TABLET [BIONPHARMA INC.]1Legacy NDC, 1 package rows20200115_828c84a6-a317-4e4d-9521-0c3865ff732f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600695amphetamine sulfate 10 MG Oral TabletPSN828c84a6-a317-4e4d-9521-0c3865ff732f1
884655amphetamine sulfate 5 MG Oral TabletPSN828c84a6-a317-4e4d-9521-0c3865ff732f1
1600695amphetamine sulfate 10 MG Oral TabletSCD828c84a6-a317-4e4d-9521-0c3865ff732f1
884655amphetamine sulfate 5 MG Oral TabletSCD828c84a6-a317-4e4d-9521-0c3865ff732f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-228-2069452022820100 TABLET in 1 BOTTLE (69452-228-20) 100 tablet2020-01-150000-00-00NoNoCurrent