Amphetamine sulfate

Product NDC
43598-898
11-digit product format
435980898
Labeler code
43598
Product ID
43598-898_6804c1a2-f648-b841-1d39-74d8624881e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine Sulfate Tablets
Dosage form
TABLET
Route
ORAL
Labeler
DR. REDDY'S LABORATORIES INC
Application
ANDA212582
Marketing category
ANDA
Marketing start
2020-03-01
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
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 SULFATE10 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
43598-898-01Amphetamine sulfate100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-898-01EA - Each43598-898e298fda2-e7ac-4749-9e31-8b88838d6e3c12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-898AMPHETAMINE SULFATE (AMPHETAMINE SULFATE TABLETS) TABLET [DR. REDDY'S LABORATORIES INC]11Current NDC, Legacy NDC, 1 package rows20230713_79b9db39-7cdc-5607-f0ce-ac2a2cfd59d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600695amphetamine sulfate 10 MG Oral TabletPSN79b9db39-7cdc-5607-f0ce-ac2a2cfd59d511
884655amphetamine sulfate 5 MG Oral TabletPSN79b9db39-7cdc-5607-f0ce-ac2a2cfd59d511
1600695amphetamine sulfate 10 MG Oral TabletSCD79b9db39-7cdc-5607-f0ce-ac2a2cfd59d511
884655amphetamine sulfate 5 MG Oral TabletSCD79b9db39-7cdc-5607-f0ce-ac2a2cfd59d511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-898-0143598089801100 TABLET in 1 BOTTLE (43598-898-01) 100 tablet2020-03-010000-00-00NoNoCurrent