AMPHETAMINE SULFATE

Product NDC
63629-2079
11-digit product format
636292079
Labeler code
63629
Product ID
63629-2079_bf0acb3d-830c-46ca-93ca-15b0cecef170
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
63629-2079-1AMPHETAMINE SULFATE100 in 1 BOTTLETABLET100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2079-1EA - Each63629-20796ce3e96b-94ba-482f-b122-f1f17e28c1da12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2079AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240418_c00bbade-3dc8-422b-8cff-f85db408bdfc.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2079-163629207901100 TABLET in 1 BOTTLE (63629-2079-1) 100 tablet2024-04-020000-00-00NoNoCurrent