Amphetamine Sulfate

Product NDC
70010-040
11-digit product format
700100040
Labeler code
70010
Product ID
70010-040_4007e92c-5f78-73ea-e063-6394a90a92a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA212619
Marketing category
ANDA
Marketing start
2019-08-15
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70010-040-012021-02-02C16284748780-1ba0f9c33-1467-a910-e053-dadaa90a0b85Amphetamine Sulfate Tablets, USP CII
70010-040-012021-01-29C16284748780-1ba0f9c33-1467-a910-e053-dadaa90a0b85Amphetamine Sulfate Tablets, USP CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70010-040-01Amphetamine Sulfate100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-040-01EA - Each70010-04045bee1fb-66f9-41d5-8af9-547c4e181c4e12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-040AMPHETAMINE SULFATE (AMPHETAMINE SULFATE) TABLET [GRANULES PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 1 package rows20250509_26dbad66-13c4-4906-88b3-ab7ee191466c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600695amphetamine sulfate 10 MG Oral TabletPSN26dbad66-13c4-4906-88b3-ab7ee191466c13
884655amphetamine sulfate 5 MG Oral TabletPSN26dbad66-13c4-4906-88b3-ab7ee191466c13
1600695amphetamine sulfate 10 MG Oral TabletSCD26dbad66-13c4-4906-88b3-ab7ee191466c13
884655amphetamine sulfate 5 MG Oral TabletSCD26dbad66-13c4-4906-88b3-ab7ee191466c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-040-0170010004001100 TABLET in 1 BOTTLE (70010-040-01) 100 tablet2019-08-150000-00-00NoNoCurrent