FDA.reportPublic FDA data

Adzenys XR-ODT

Product NDC
70165-025
11-digit product format
701650025
Labeler code
70165
Product ID
70165-025_512c5af5-6bf8-ace1-e063-6394a90ad807
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Neos Therapeutics Brands, LLC
Application
NDA204326
Marketing category
NDA
Marketing start
2016-02-16
Substance
AMPHETAMINE
Active strength
15.7 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Adzenys XR-ODT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE15.7 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCK833KGX7E
Rxcui1739803, 1739809, 1739813, 1739815, 1739819, 1739821, 1739825, 1739827, 1739831, 1739833, 1739837, 1739839

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
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70165-025-30Adzenys XR-ODT6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING615
70165-025-30Adzenys XR-ODT30 in 1 CARTONTABLET, ORALLY DISINTEGRATING3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70165-025-30EA - Each70165-025553433d4-e6f5-4356-8ff4-6698bccf8c2212016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70165-025ADZENYS XR-ODT (AMPHETAMINE) TABLET, ORALLY DISINTEGRATING [NEOS THERAPEUTICS BRANDS, LLC]13Current NDC, Legacy NDC, 2 package rows20250412_c1179269-00b5-48ea-972d-31e614e99b7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739809Adzenys XR-ODT 12.5 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739815Adzenys XR-ODT 15.7 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739821Adzenys XR-ODT 18.8 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739827Adzenys XR-ODT 3.1 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739833Adzenys XR-ODT 6.3 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739839Adzenys XR-ODT 9.4 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739803amphetamine 12.5 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739813amphetamine 15.7 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739819amphetamine 18.8 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739825amphetamine 3.1 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739831amphetamine 6.3 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
1739837amphetamine 9.4 MG 24HR Extended Release Distintegrating Oral TabletPSNc1179269-00b5-48ea-972d-31e614e99b7e15
173980924 HR amphetamine 12.5 MG Extended Release Oral Tablet [Adzenys]SBDc1179269-00b5-48ea-972d-31e614e99b7e15
173981524 HR amphetamine 15.7 MG Extended Release Oral Tablet [Adzenys]SBDc1179269-00b5-48ea-972d-31e614e99b7e15
173982124 HR amphetamine 18.8 MG Extended Release Oral Tablet [Adzenys]SBDc1179269-00b5-48ea-972d-31e614e99b7e15
173982724 HR amphetamine 3.1 MG Extended Release Oral Tablet [Adzenys]SBDc1179269-00b5-48ea-972d-31e614e99b7e15
173983324 HR amphetamine 6.3 MG Extended Release Oral Tablet [Adzenys]SBDc1179269-00b5-48ea-972d-31e614e99b7e15
173983924 HR amphetamine 9.4 MG Extended Release Oral Tablet [Adzenys]SBDc1179269-00b5-48ea-972d-31e614e99b7e15
173980324 HR amphetamine 12.5 MG Extended Release Oral TabletSCDc1179269-00b5-48ea-972d-31e614e99b7e15
173981324 HR amphetamine 15.7 MG Extended Release Oral TabletSCDc1179269-00b5-48ea-972d-31e614e99b7e15
173981924 HR amphetamine 18.8 MG Extended Release Oral TabletSCDc1179269-00b5-48ea-972d-31e614e99b7e15
173982524 HR amphetamine 3.1 MG Extended Release Oral TabletSCDc1179269-00b5-48ea-972d-31e614e99b7e15
173983124 HR amphetamine 6.3 MG Extended Release Oral TabletSCDc1179269-00b5-48ea-972d-31e614e99b7e15
173983724 HR amphetamine 9.4 MG Extended Release Oral TabletSCDc1179269-00b5-48ea-972d-31e614e99b7e15
1739809Adzenys 12.5 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739815Adzenys 15.7 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739821Adzenys 18.8 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739827Adzenys 3.1 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739833Adzenys 6.3 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739839Adzenys 9.4 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739803amphetamine 12.5 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739813amphetamine 15.7 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739819amphetamine 18.8 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739825amphetamine 3.1 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739831amphetamine 6.3 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15
1739837amphetamine 9.4 MG 24 HR Extended Release Distintegrating Oral TabletSYc1179269-00b5-48ea-972d-31e614e99b7e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70165-025-307016500253030 BLISTER PACK in 1 CARTON (70165-025-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK30 blister pack2016-02-160000-00-00NoNoCurrent