Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Product NDC: 16714-953
11-digit product format: 167140953
Labeler code: 16714
Product ID: 16714-953_74be2e0b-bbf0-448a-b035-316834bb4118
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA202424
Marketing category: ANDA
Marketing start: 2019-03-20
Substance: AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength: 5; 5; 5; 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 Stimulant [EPC], Central Nervous System Stimulation [PE], 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: 2026-12-31
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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202424-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2013-11-27
A202424-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2013-11-27
A202424-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2013-11-27
A202424-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2013-11-27
A202424-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2013-11-27
A202424-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2013-11-27
A202424-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2013-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
A202424-001	AB
A202424-002	AB
A202424-003	AB
A202424-004	AB
A202424-005	AB
A202424-006	AB
A202424-007	AB

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.

Product history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2013-11-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2013-11-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2013-11-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2013-11-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2013-11-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2013-11-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2013-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2013-11-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2013-11-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2013-11-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2013-11-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2013-11-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2013-11-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2013-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202424-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2013-11-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2013-11-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2013-11-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2013-11-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2013-11-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2013-11-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2013-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202424-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2013-11-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2013-11-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2013-11-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2013-11-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2013-11-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2013-11-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2013-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2013-11-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2013-11-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2013-11-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2013-11-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2013-11-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	AB	2013-11-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	AB	2013-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202424-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	AB	2013-11-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202424-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	AB	2013-11-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202424-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	AB	2013-11-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202424-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	AB	2013-11-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202424-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	AB	2013-11-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-004	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-005	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-006	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202424-007	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-004	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-005	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-006	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202424-007	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202424-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-004	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-005	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-006	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202424-007	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202424-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-004	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-005	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-006	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202424-007	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-004	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-005	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-006	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202424-007	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202424-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202424-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202424-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202424-004	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A202424-005	AB	1	`f41ea6bd6efb…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE	Bryant Ranch Prepack	ff1e5518-0aa6-4bc9-bc87-8a6a124bc95a	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202424 application number: ANDA202424
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE	NorthStar RxLLC	8468623b-9584-43ef-ac16-fc15b060624c	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202424 application number: ANDA202424 ndc (product): 16714-953
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE	Aurolife Pharma, LLC	a582d57f-d191-4ca5-b105-585b2d8a0e3e	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202424 application number: ANDA202424

Additional Listing Data#

Finished product: Yes
Brand name base: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE SACCHARATE	5 mg/1
AMPHETAMINE ASPARTATE MONOHYDRATE	5 mg/1
DEXTROAMPHETAMINE SULFATE	5 mg/1
AMPHETAMINE SULFATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G83415V073	Internal UNII lookup
JJ768O327N	Internal UNII lookup
O1ZPV620O4	Internal UNII lookup
6DPV8NK46S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
541363	Internal RxNorm lookup
541878	Internal RxNorm lookup
541892	Internal RxNorm lookup
577957	Internal RxNorm lookup
577961	Internal RxNorm lookup
1009145	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
8468623b-9584-43ef-ac16-fc15b060624c	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
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	5	20230426
8170729e-5ba4-46f9-830f-5f0fae5942ce	Product name	1	20230103
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
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27	Product name	5	20190913
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	4	20171211
57953747-955c-4dd8-9164-49d8ea877eae	Product name	1	20171113
fcc7ea58-a369-4e91-b092-5cde9ac2669f	Product name	1	20160224
ffdf7f68-0f44-4dd6-a026-336dcb345fc4	Product name	1	20151109

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-953-01	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	100 in 1 BOTTLE	TABLET	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-953-01	EA - Each	16714-953	c9954af4-f3a9-458b-84ab-796102ed3783	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-953	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [NORTHSTAR RXLLC]	6	Current NDC, Legacy NDC, 1 package rows	20240719_8468623b-9584-43ef-ac16-fc15b060624c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O1ZPV620O4	AMPHETAMINE ASPARTATE MONOHYDRATE	851591-76-9	AMPHETAMINE ASPARTATE MONOHYDRATE
6DPV8NK46S	AMPHETAMINE SULFATE	60-13-9	AMPHETAMINE SULFATE
G83415V073	DEXTROAMPHETAMINE SACCHARATE	350708-40-6	DEXTROAMPHETAMINE SACCHARATE
JJ768O327N	DEXTROAMPHETAMINE SULFATE	51-63-8	DEXTROAMPHETAMINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
541878	dextroamphetamine saccharate 1.25 MG / amphetamine aspartate 1.25 MG / dextroamphetamine sulfate 1.25 MG / amphetamine sulfate 1.25 MG Oral Tablet	PSN	8468623b-9584-43ef-ac16-fc15b060624c	8
1009145	dextroamphetamine saccharate 1.875 MG / amphetamine aspartate 1.875 MG / dextroamphetamine sulfate 1.875 MG / amphetamine sulfate 1.875 MG Oral Tablet	PSN	8468623b-9584-43ef-ac16-fc15b060624c	8
541892	dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG Oral Tablet	PSN	8468623b-9584-43ef-ac16-fc15b060624c	8
577957	dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG Oral Tablet	PSN	8468623b-9584-43ef-ac16-fc15b060624c	8
577961	dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG Oral Tablet	PSN	8468623b-9584-43ef-ac16-fc15b060624c	8
541363	dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral Tablet	PSN	8468623b-9584-43ef-ac16-fc15b060624c	8
541878	amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Oral Tablet	SCD	8468623b-9584-43ef-ac16-fc15b060624c	8
1009145	amphetamine aspartate 1.875 MG / amphetamine sulfate 1.875 MG / dextroamphetamine saccharate 1.875 MG / dextroamphetamine sulfate 1.875 MG Oral Tablet	SCD	8468623b-9584-43ef-ac16-fc15b060624c	8
541892	amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral Tablet	SCD	8468623b-9584-43ef-ac16-fc15b060624c	8
577957	amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Oral Tablet	SCD	8468623b-9584-43ef-ac16-fc15b060624c	8
577961	amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral Tablet	SCD	8468623b-9584-43ef-ac16-fc15b060624c	8
541363	amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral Tablet	SCD	8468623b-9584-43ef-ac16-fc15b060624c	8
541892	mixed amphetamine salts 10 MG Oral Tablet	SY	8468623b-9584-43ef-ac16-fc15b060624c	8
577957	mixed amphetamine salts 15 MG Oral Tablet	SY	8468623b-9584-43ef-ac16-fc15b060624c	8
577961	mixed amphetamine salts 20 MG Oral Tablet	SY	8468623b-9584-43ef-ac16-fc15b060624c	8
541363	mixed amphetamine salts 30 MG Oral Tablet	SY	8468623b-9584-43ef-ac16-fc15b060624c	8
541878	mixed amphetamine salts 5 MG Oral Tablet	SY	8468623b-9584-43ef-ac16-fc15b060624c	8
1009145	mixed amphetamine salts 7.5 MG Oral Tablet	SY	8468623b-9584-43ef-ac16-fc15b060624c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-953-01	16714095301	100 TABLET in 1 BOTTLE (16714-953-01)	100 tablet	2019-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets CII Rx Only	NorthStar RxLLC \| Aurolife Pharma LLC	2025-12-12	Human Prescription Drug Label	8