Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate

Product NDC
60687-509
11-digit product format
606870509
Labeler code
60687
Product ID
60687-509_ee9facb0-e55b-e7a1-e053-2a95a90a273a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA206159
Marketing category
ANDA
Marketing start
2020-07-10
Marketing end
2023-06-30
Substance
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-509-25EA - Each60687-5095ba9d32e-4533-4e62-a270-d314d6e12c6912020-07-13
60687-509-95EA - Each60687-50937e3f2ba-f921-4480-9516-c227506c5d3912020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-509-256068705092530 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-509-25) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-509-95) 30 blister pack2020-05-010000-00-00NoNoCurrent