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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204326-001	ADZENYS XR-ODT	AMPHETAMINE	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27
N204326-002	ADZENYS XR-ODT	AMPHETAMINE	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27
N204326-003	ADZENYS XR-ODT	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27
N204326-004	ADZENYS XR-ODT	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27
N204326-005	ADZENYS XR-ODT	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27
N204326-006	ADZENYS XR-ODT	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2016-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N204326-001	AB
N204326-002	AB
N204326-003	AB
N204326-004	AB
N204326-005	AB
N204326-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N204326-001	8840924	2026-04-09	Drug product	2016-02-26
N204326-001	8709491	2032-06-28	Drug product	2016-02-26
N204326-001	9017731	2032-06-28	Drug product	2016-02-26
N204326-001	9265737	2032-06-28	Drug product	2016-02-26
N204326-001	9839619	2032-06-28	Drug product	2024-04-22
N204326-002	8840924	2026-04-09	Drug product	2016-02-26
N204326-002	8709491	2032-06-28	Drug product
N204326-002	9017731	2032-06-28	Drug product
N204326-002	9265737	2032-06-28	Drug product
N204326-002	9839619	2032-06-28	Drug product	2024-04-22
N204326-003	8840924	2026-04-09	Drug product	2016-02-26
N204326-003	8709491	2032-06-28	Drug product
N204326-003	9017731	2032-06-28	Drug product
N204326-003	9265737	2032-06-28	Drug product
N204326-003	9839619	2032-06-28	Drug product	2024-04-22
N204326-004	8840924	2026-04-09	Drug product	2016-02-26
N204326-004	8709491	2032-06-28	Drug product
N204326-004	9017731	2032-06-28	Drug product
N204326-004	9265737	2032-06-28	Drug product
N204326-004	9839619	2032-06-28	Drug product	2024-04-22
N204326-005	8840924	2026-04-09	Drug product	2016-02-26
N204326-005	8709491	2032-06-28	Drug product
N204326-005	9017731	2032-06-28	Drug product
N204326-005	9265737	2032-06-28	Drug product
N204326-005	9839619	2032-06-28	Drug product	2024-04-22
N204326-006	8840924	2026-04-09	Drug product	2016-02-26
N204326-006	8709491	2032-06-28	Drug product
N204326-006	9017731	2032-06-28	Drug product
N204326-006	9265737	2032-06-28	Drug product
N204326-006	9839619	2032-06-28	Drug product	2024-04-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N204326-001	ADZENYS XR-ODT	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	ADZENYS XR-ODT	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	ADZENYS XR-ODT	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	ADZENYS XR-ODT	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	ADZENYS XR-ODT	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD	2016-01-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	ADZENYS XR-ODT	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	RLD, RS	2016-01-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N204326-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N204326-001	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-001	8709491	2032-06-28	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-001	9017731	2032-06-28	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-001	9265737	2032-06-28	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-001	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	8709491	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	9017731	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	9265737	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-002	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	8709491	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	9017731	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	9265737	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-003	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	8709491	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	9017731	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	9265737	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-004	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	8709491	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	9017731	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	9265737	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-005	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	8840924	2026-04-09	Drug product	2016-02-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	8709491	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	9017731	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	9265737	2032-06-28	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204326-006	9839619	2032-06-28	Drug product	2024-04-22	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adzenys XR-ODT	AMPHETAMINE	Neos Therapeutics Brands, LLC	c1179269-00b5-48ea-972d-31e614e99b7e	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204326 application number: NDA204326 ndc (product): 70165-025
Amphetamine Extended-Release	AMPHETAMINE EXTENDED-RELEASE	Neos Therapeutics, LP	48d0f55c-f847-4d26-b2ed-94b5a2770228	2025-09-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204326 application number: NDA204326

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMPHETAMINE	15.7 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CK833KGX7E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1739803	Internal RxNorm lookup
1739809	Internal RxNorm lookup
1739813	Internal RxNorm lookup
1739815	Internal RxNorm lookup
1739819	Internal RxNorm lookup
1739821	Internal RxNorm lookup
1739825	Internal RxNorm lookup
1739827	Internal RxNorm lookup
1739831	Internal RxNorm lookup
1739833	Internal RxNorm lookup
1739837	Internal RxNorm lookup
1739839	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c1179269-00b5-48ea-972d-31e614e99b7e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21	Product name	7	20250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2b	Product name	2	20250616
8b92ab59-8b26-4c89-a2d6-8d5140526ec6	Product name	3	20231213
4496d022-9224-4ee0-943a-50fbe6cd7123	Product name	2	20220901
2a7aa275-a4ca-44eb-971f-47427a374085	Product name	9	20220615
93730fbf-8b45-4623-b27d-cf03825d04b3	Product name	5	20220314
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
57953747-955c-4dd8-9164-49d8ea877eae	Product name	1	20171113
fcc7ea58-a369-4e91-b092-5cde9ac2669f	Product name	1	20160224
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70165-025-30	Adzenys XR-ODT	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6		15
70165-025-30	Adzenys XR-ODT	30 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	30		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70165-025-30	EA - Each	70165-025	553433d4-e6f5-4356-8ff4-6698bccf8c22	1	2016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70165-025	ADZENYS XR-ODT (AMPHETAMINE) TABLET, ORALLY DISINTEGRATING [NEOS THERAPEUTICS BRANDS, LLC]	13	Current NDC, Legacy NDC, 2 package rows	20250412_c1179269-00b5-48ea-972d-31e614e99b7e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CK833KGX7E	AMPHETAMINE	300-62-9	AMPHETAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1739809	Adzenys XR-ODT 12.5 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739815	Adzenys XR-ODT 15.7 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739821	Adzenys XR-ODT 18.8 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739827	Adzenys XR-ODT 3.1 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739833	Adzenys XR-ODT 6.3 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739839	Adzenys XR-ODT 9.4 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739803	amphetamine 12.5 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739813	amphetamine 15.7 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739819	amphetamine 18.8 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739825	amphetamine 3.1 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739831	amphetamine 6.3 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739837	amphetamine 9.4 MG 24HR Extended Release Distintegrating Oral Tablet	PSN	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739809	24 HR amphetamine 12.5 MG Extended Release Oral Tablet [Adzenys]	SBD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739815	24 HR amphetamine 15.7 MG Extended Release Oral Tablet [Adzenys]	SBD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739821	24 HR amphetamine 18.8 MG Extended Release Oral Tablet [Adzenys]	SBD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739827	24 HR amphetamine 3.1 MG Extended Release Oral Tablet [Adzenys]	SBD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739833	24 HR amphetamine 6.3 MG Extended Release Oral Tablet [Adzenys]	SBD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739839	24 HR amphetamine 9.4 MG Extended Release Oral Tablet [Adzenys]	SBD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739803	24 HR amphetamine 12.5 MG Extended Release Oral Tablet	SCD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739813	24 HR amphetamine 15.7 MG Extended Release Oral Tablet	SCD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739819	24 HR amphetamine 18.8 MG Extended Release Oral Tablet	SCD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739825	24 HR amphetamine 3.1 MG Extended Release Oral Tablet	SCD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739831	24 HR amphetamine 6.3 MG Extended Release Oral Tablet	SCD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739837	24 HR amphetamine 9.4 MG Extended Release Oral Tablet	SCD	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739809	Adzenys 12.5 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739815	Adzenys 15.7 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739821	Adzenys 18.8 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739827	Adzenys 3.1 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739833	Adzenys 6.3 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739839	Adzenys 9.4 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739803	amphetamine 12.5 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739813	amphetamine 15.7 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739819	amphetamine 18.8 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739825	amphetamine 3.1 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739831	amphetamine 6.3 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15
1739837	amphetamine 9.4 MG 24 HR Extended Release Distintegrating Oral Tablet	SY	c1179269-00b5-48ea-972d-31e614e99b7e	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70165-025-30	70165002530	30 BLISTER PACK in 1 CARTON (70165-025-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	30 blister pack	2016-02-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adzenys XR-ODT	Neos Therapeutics Brands, LLC \| Aphena Pharma Solutions \| Halo Pharmaceuticals, Inc	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	15