Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

Product NDC: 66993-596
Requested package NDC: 66993-596-02
11-digit product format: 669930596
Labeler code: 66993
Product ID: 66993-596_88228827-17de-42dd-a08c-aacf516e0156
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Prasco Laboratories
Application: NDA021303
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-04-02
Marketing end: 2027-04-30
Substance: AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength: 3.75; 3.75; 3.75; 3.75 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
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
N021303-001	ADDERALL XR 10	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11
N021303-002	ADDERALL XR 20	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11
N021303-003	ADDERALL XR 30	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11
N021303-004	ADDERALL XR 25	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22
N021303-005	ADDERALL XR 5	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22
N021303-006	ADDERALL XR 15	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021303-001	AB1
N021303-002	AB1
N021303-003	AB1
N021303-004	AB1
N021303-005	AB1
N021303-006	AB1

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 7 · 246 observed 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
2026-02-19 14:30 UTC	2026-02	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-005	ADDERALL XR 5	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-006	ADDERALL XR 15	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-001	ADDERALL XR 10	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-002	ADDERALL XR 20	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2001-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-003	ADDERALL XR 30	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2001-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-004	ADDERALL XR 25	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2002-05-22	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021303-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021303-006	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-004	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-005	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021303-006	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021303-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-004	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-005	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021303-006	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-004	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-005	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021303-006	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-004	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-005	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021303-006	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-004	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-005	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021303-006	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021303-004	AB1	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021303-001	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-001	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-001	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-001	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-002	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-003	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-004	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-005	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	6322819*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	6605300*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	RE41148*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021303-006	RE42096*PED	2019-04-21	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021303-001	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-001	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-001	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-001	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-002	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-003	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	6322819*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	6605300*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	RE41148*PED	2019-04-21	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021303-004	RE42096*PED	2019-04-21	Pediatric extension	`3f01610625f2…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE SACCHARATE	3.75 mg/1
AMPHETAMINE ASPARTATE MONOHYDRATE	3.75 mg/1
DEXTROAMPHETAMINE SULFATE	3.75 mg/1
AMPHETAMINE SULFATE	3.75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O1ZPV620O4	Internal UNII lookup
G83415V073	Internal UNII lookup
JJ768O327N	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
861221	Internal RxNorm lookup
861223	Internal RxNorm lookup
861225	Internal RxNorm lookup
861227	Internal RxNorm lookup
861232	Internal RxNorm lookup
861237	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
f85af6ee-9029-42de-adea-6dbb8642952c	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
66993-596-02	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-596-02	EA - Each	66993-596	90115be0-a481-4873-ad50-0371c442e3c2	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-596	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [PRASCO LABORATORIES]	8	Current NDC, Legacy NDC, 1 package rows	20240613_f85af6ee-9029-42de-adea-6dbb8642952c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
Adderall XR	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE	Takeda Pharmaceuticals America, Inc.	aff45863-ffe1-4d4f-8acf-c7081512a6c0	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021303 application number: NDA021303
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE	Sandoz Inc	6f637e8d-7c2e-47fa-a43c-3250c51aed77	2023-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021303 application number: NDA021303
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE	Prasco Laboratories	f85af6ee-9029-42de-adea-6dbb8642952c	2023-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021303 application number: NDA021303 ndc (package): 66993-596-02 ndc (product): 66993-596 ndc11 (package): 66993059602

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
861237	dextroamphetamine saccharate 1.25 MG / amphetamine aspartate 1.25 MG / dextroamphetamine sulfate 1.25 MG / amphetamine sulfate 1.25 MG 24HR Extended Release Oral Capsule	PSN	f85af6ee-9029-42de-adea-6dbb8642952c	8
861221	dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG 24HR Extended Release Oral Capsule	PSN	f85af6ee-9029-42de-adea-6dbb8642952c	8
861223	dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG 24HR Extended Release Oral Capsule	PSN	f85af6ee-9029-42de-adea-6dbb8642952c	8
861225	dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG 24HR Extended Release Oral Capsule	PSN	f85af6ee-9029-42de-adea-6dbb8642952c	8
861227	dextroamphetamine saccharate 6.25 MG / amphetamine aspartate 6.25 MG / dextroamphetamine sulfate 6.25 MG / amphetamine sulfate 6.25 MG 24HR Extended Release Oral Capsule	PSN	f85af6ee-9029-42de-adea-6dbb8642952c	8
861232	dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG 24HR Extended Release Oral Capsule	PSN	f85af6ee-9029-42de-adea-6dbb8642952c	8
861237	24 HR amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Extended Release Oral Capsule	SCD	f85af6ee-9029-42de-adea-6dbb8642952c	8
861221	24 HR amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Extended Release Oral Capsule	SCD	f85af6ee-9029-42de-adea-6dbb8642952c	8
861223	24 HR amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Extended Release Oral Capsule	SCD	f85af6ee-9029-42de-adea-6dbb8642952c	8
861225	24 HR amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Extended Release Oral Capsule	SCD	f85af6ee-9029-42de-adea-6dbb8642952c	8
861227	24 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral Capsule	SCD	f85af6ee-9029-42de-adea-6dbb8642952c	8
861232	24 HR amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Extended Release Oral Capsule	SCD	f85af6ee-9029-42de-adea-6dbb8642952c	8
861237	amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG 24 HR Extended Release Oral Capsule	SY	f85af6ee-9029-42de-adea-6dbb8642952c	8
861221	amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG 24 HR Extended Release Oral Capsule	SY	f85af6ee-9029-42de-adea-6dbb8642952c	8
861223	amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG 24 HR Extended Release Oral Capsule	SY	f85af6ee-9029-42de-adea-6dbb8642952c	8
861225	amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG 24 HR Extended Release Oral Capsule	SY	f85af6ee-9029-42de-adea-6dbb8642952c	8
861227	amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 24 HR Extended Release Oral Capsule	SY	f85af6ee-9029-42de-adea-6dbb8642952c	8
861232	amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG 24 HR Extended Release Oral Capsule	SY	f85af6ee-9029-42de-adea-6dbb8642952c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-596-02	66993059602	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-596-02)	2009-04-02	2027-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXTROAMPHETAMINE SACCHARATE	Prasco Laboratories \| Cambrex Charles City, Inc \| Patheon Manufacturing Services LLC \| Unither Manufacturing LLC \| Sharp Packaging Services, LLC	2023-10-13	HUMAN PRESCRIPTION DRUG LABEL	8