dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product NDC: 70010-034
11-digit product format: 700100034
Labeler code: 70010
Product ID: 70010-034_51ac9d68-0275-7d80-e063-6294a90a5ccb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA217027
Marketing category: ANDA
Marketing start: 2023-02-20
Substance: AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength: 7.5; 7.5; 7.5; 7.5 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: 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	Approval date
A217027-001	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	2023-01-23
A217027-002	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	2023-01-23
A217027-003	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	2023-01-23
A217027-004	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	2023-01-23
A217027-005	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	2023-01-23
A217027-006	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	2023-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217027-001	AB1
A217027-002	AB1
A217027-003	AB1
A217027-004	AB1
A217027-005	AB1
A217027-006	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 4 · 138 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
2026-02-19 14:30 UTC	2026-02	A217027-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217027-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217027-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217027-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217027-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217027-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217027-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217027-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217027-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217027-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217027-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217027-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217027-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217027-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217027-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217027-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	2023-01-23	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 138 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	A217027-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217027-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217027-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217027-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217027-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217027-006	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-004	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-005	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217027-006	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217027-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217027-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217027-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217027-004	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217027-005	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217027-006	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-004	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-005	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217027-006	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-004	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-005	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217027-006	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-004	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-005	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217027-006	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217027-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217027-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217027-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217027-004	AB1	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE SACCHARATE	7.5 mg/1
AMPHETAMINE ASPARTATE MONOHYDRATE	7.5 mg/1
DEXTROAMPHETAMINE SULFATE	7.5 mg/1
AMPHETAMINE SULFATE	7.5 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
8c672e06-0778-4a7d-b398-5bcbf2a73f12	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
70010-034-01	dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-034-01	EA - Each	70010-034	a9d99645-837a-4fb5-be4d-3f5da0d4f01e	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-034	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]	4	Current NDC, 1 package rows	20241019_8c672e06-0778-4a7d-b398-5bcbf2a73f12.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE	Granules Pharmaceuticals Inc.	8c672e06-0778-4a7d-b398-5bcbf2a73f12	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217027 application number: ANDA217027 ndc (product): 70010-034

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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
861225	dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG 24HR Extended Release Oral Capsule	PSN	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
861225	24 HR amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Extended Release Oral Capsule	SCD	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
861225	amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG 24 HR Extended Release Oral Capsule	SY	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6
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	8c672e06-0778-4a7d-b398-5bcbf2a73f12	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70010-034-01	70010003401	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-034-01)	2023-02-20	No	No	Current