AMPHETAMINE SULFATE

Product NDC
63629-2078
11-digit product format
636292078
Labeler code
63629
Product ID
63629-2078_50035f9b-feee-47ca-8786-af69aebc0cfb
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
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
Rxcui1600695

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
63629-2078-1AMPHETAMINE SULFATE100 in 1 BOTTLETABLET100106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2078-1EA - Each63629-20788fe9cbe9-ed62-4c22-b3fc-33637a6b141312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2078AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20250213_9eb84b3c-2147-42dd-8053-6afd1a88b0c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600695amphetamine sulfate 10 MG Oral TabletPSN9eb84b3c-2147-42dd-8053-6afd1a88b0c1106
1600695amphetamine sulfate 10 MG Oral TabletSCD9eb84b3c-2147-42dd-8053-6afd1a88b0c1106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2078-163629207801100 TABLET in 1 BOTTLE (63629-2078-1) 100 tablet2021-12-210000-00-00NoNoCurrent