Mixed Salts of a Single Entity Amphetamine Product

Product NDC: 0406-8955
11-digit product format: 004068955
Labeler code: 0406
Product ID: 0406-8955_28a6fbe6-9500-4f14-9e12-041e302a0a24
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: SpecGx LLC
Application: ANDA211547
Marketing category: ANDA
Marketing start: 2019-04-22
Substance: DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE
Active strength: 6.25; 6.25; 6.25; 6.25 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A211547-001	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	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22
A211547-002	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	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22
A211547-003	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	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22
A211547-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22
A211547-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22
A211547-006	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	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211547-001	AB1
A211547-002	AB1
A211547-003	AB1
A211547-004	AB1
A211547-005	AB1
A211547-006	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 · 258 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
2026-09-14 22:38:34	2026-08	A211547-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211547-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211547-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211547-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211547-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211547-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211547-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211547-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211547-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211547-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211547-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211547-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211547-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211547-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211547-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211547-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211547-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211547-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211547-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211547-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211547-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211547-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211547-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211547-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211547-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211547-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211547-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211547-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211547-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211547-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211547-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211547-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211547-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211547-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211547-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211547-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211547-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211547-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211547-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211547-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2019-04-22	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A211547-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A211547-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211547-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211547-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211547-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211547-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211547-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A211547-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211547-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211547-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211547-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211547-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211547-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A211547-006	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211547-001	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211547-002	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211547-003	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211547-004	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211547-005	AB1	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211547-006	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211547-001	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211547-002	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211547-003	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211547-004	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211547-005	AB1	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211547-006	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211547-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211547-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211547-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211547-004	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211547-005	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211547-006	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211547-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211547-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211547-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211547-004	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211547-005	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211547-006	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211547-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211547-002	AB	1	`9b2671bbb829…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Mixed Salts of a Single Entity Amphetamine Product
Brand name suffix: XR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	6.25 mg/1
DEXTROAMPHETAMINE SACCHARATE	6.25 mg/1
AMPHETAMINE ASPARTATE MONOHYDRATE	6.25 mg/1
AMPHETAMINE SULFATE	6.25 mg/1

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
0406-8955-01	Mixed Salts of a Single Entity Amphetamine ProductXR	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-8955-01	EA - Each	0406-8955	8747a574-28f3-40ff-b635-e067b5961da0	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-8955	MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT XR (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [SPECGX LLC]	15	Current NDC, Legacy NDC, 1 package rows	20240724_60a2834c-38a2-480e-b89c-563e9cf0c9c3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JJ768O327N	DEXTROAMPHETAMINE SULFATE	51-63-8	DEXTROAMPHETAMINE SULFATE
G83415V073	DEXTROAMPHETAMINE SACCHARATE	350708-40-6	DEXTROAMPHETAMINE SACCHARATE
O1ZPV620O4	AMPHETAMINE ASPARTATE MONOHYDRATE	851591-76-9	AMPHETAMINE ASPARTATE MONOHYDRATE
6DPV8NK46S	AMPHETAMINE SULFATE	60-13-9	AMPHETAMINE 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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
861225	dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG 24HR Extended Release Oral Capsule	PSN	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
861225	24 HR amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Extended Release Oral Capsule	SCD	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
861225	amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG 24 HR Extended Release Oral Capsule	SY	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16
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	60a2834c-38a2-480e-b89c-563e9cf0c9c3	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-8955-01	00406895501	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8955-01)	2019-04-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mixed Salts of a Single Entity Amphetamine Product XR	SpecGx LLC	2026-09-29	HUMAN PRESCRIPTION DRUG LABEL	17