AMPHETAMINE SULFATE

Product NDC
0527-2524
11-digit product format
005272524
Labeler code
0527
Product ID
0527-2524_23880d0f-9eea-4ef3-95aa-10fc11fcfa6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA212901
Marketing category
ANDA
Marketing start
2020-05-25
Substance
AMPHETAMINE SULFATE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMPHETAMINE SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE SULFATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6DPV8NK46S
Rxcui884655, 1600695

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-2524-37AMPHETAMINE SULFATE100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-2524-37EA - Each0527-2524657c665e-a389-4aad-b9ad-e0981f8e758912020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-2524AMPHETAMINE SULFATE TABLET [LANNETT COMPANY, INC.]7Current NDC, Legacy NDC, 1 package rows20240123_85a015a7-a1a0-4b04-8bc4-7aacd0c84742.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884655amphetamine sulfate 5 MG Oral TabletPSNc00bbade-3dc8-422b-8cff-f85db408bdfc104
884655amphetamine sulfate 5 MG Oral TabletSCDc00bbade-3dc8-422b-8cff-f85db408bdfc104
884655amphetamine sulfate 5 MG Oral TabletPSN698171ee-4328-476a-b71c-58aa6dc93b23101
884655amphetamine sulfate 5 MG Oral TabletSCD698171ee-4328-476a-b71c-58aa6dc93b23101
1600695amphetamine sulfate 10 MG Oral TabletPSN85a015a7-a1a0-4b04-8bc4-7aacd0c847427
884655amphetamine sulfate 5 MG Oral TabletPSN85a015a7-a1a0-4b04-8bc4-7aacd0c847427
1600695amphetamine sulfate 10 MG Oral TabletSCD85a015a7-a1a0-4b04-8bc4-7aacd0c847427
884655amphetamine sulfate 5 MG Oral TabletSCD85a015a7-a1a0-4b04-8bc4-7aacd0c847427

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-2524-3700527252437100 TABLET in 1 BOTTLE (0527-2524-37) 100 tablet2020-06-010000-00-00NoNoCurrent