Dextroamphetamine Saccharate, Amphetamine Aspartate (monohydrate), Dextroamphetamine Sulfate, Amphetamine Sulfate

Product NDC: 0378-4547
11-digit product format: 003784547
Labeler code: 0378
Product ID: 0378-4547_ad7e6098-3e81-4a71-bd04-7fd6210f3a38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextroamphetamine, amphetamine, dextroamphetamine, amphetamine
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA206721
Marketing category: ANDA
Marketing start: 2015-11-10
Marketing end: 0000-00-00
Substance: DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
Active strength: 8 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0378-4547		D	Discontinued by firm		2026-10-05
excluded package	package	0378-4547	0378-4547-01	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-4547-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-4547-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-4547-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-4547-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-4547-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-4547-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-4547-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-4547-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-4547-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-4547-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-4547-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-4547-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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	Approval date
A206721-001	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	2015-11-10
A206721-002	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	2015-11-10
A206721-003	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	2015-11-10
A206721-004	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	2015-11-10
A206721-005	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	2015-11-10
A206721-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	2015-11-10
A206721-007	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	2015-11-10

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 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206721-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	2015-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206721-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	2015-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206721-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	2015-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206721-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	2015-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206721-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	2015-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206721-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	2015-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206721-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	2015-11-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206721-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	2015-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206721-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	2015-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206721-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	2015-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206721-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	2015-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206721-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	2015-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206721-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	2015-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206721-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	2015-11-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206721-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	2015-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206721-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	2015-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206721-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	2015-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206721-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	2015-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206721-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	2015-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206721-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	2015-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206721-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	2015-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206721-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	2015-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206721-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	2015-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206721-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	2015-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206721-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	2015-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206721-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	2015-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206721-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	2015-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206721-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	2015-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206721-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	2015-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206721-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	2015-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206721-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	2015-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206721-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	2015-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206721-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	2015-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206721-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	TABLET / ORAL	2015-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206721-007	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	TABLET / ORAL	2015-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206721-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	TABLET / ORAL	2015-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206721-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.875MG;1.875MG;1.875MG;1.875MG	TABLET / ORAL	2015-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206721-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	TABLET / ORAL	2015-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206721-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.125MG;3.125MG;3.125MG;3.125MG	TABLET / ORAL	2015-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206721-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	TABLET / ORAL	2015-11-10	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A206721-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206721-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206721-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206721-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206721-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206721-006	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206721-007	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206721-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206721-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206721-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206721-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206721-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206721-006	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206721-007	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206721-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206721-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206721-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206721-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206721-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206721-006	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206721-007	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206721-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206721-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206721-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206721-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206721-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206721-006	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206721-007	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206721-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206721-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206721-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206721-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206721-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206721-006	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206721-007	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206721-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206721-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206721-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206721-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206721-005	AB	1	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4547-01	EA - Each	0378-4547	379a5565-4d6b-43ac-a070-4cf6254982a2	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMPHETAMINE ASPARTATE	ACTIVE INGREDIENT	H527KAP6L5	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
AMPHETAMINE SULFATE	ACTIVE INGREDIENT	6DPV8NK46S	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
DEXTROAMPHETAMINE SACCHARATE	ACTIVE INGREDIENT	G83415V073	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
DEXTROAMPHETAMINE SULFATE	ACTIVE INGREDIENT	JJ768O327N	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
AMPHETAMINE	ACTIVE MOIETY	CK833KGX7E	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
DEXTROAMPHETAMINE	ACTIVE MOIETY	TZ47U051FI	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE (MONOHYDRATE), DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE (DEXTROAMPHETAMINE, AMPHETAMINE, DEXTROAMPHETAMINE, AMPHETAMINE) TABLET [MYLAN PHARMACEUTICALS INC.]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G83415V073	DEXTROAMPHETAMINE SACCHARATE	350708-40-6	DEXTROAMPHETAMINE SACCHARATE
H527KAP6L5	AMPHETAMINE ASPARTATE	25333-81-7	AMPHETAMINE ASPARTATE
JJ768O327N	DEXTROAMPHETAMINE SULFATE	51-63-8	DEXTROAMPHETAMINE SULFATE
6DPV8NK46S	AMPHETAMINE SULFATE	60-13-9	AMPHETAMINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-4547-01	00378454701	100 TABLET in 1 BOTTLE, PLASTIC (0378-4547-01)	100 tablet	2015-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXTROAMPHETAMINE SACCHARATE - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2015-05-08	HUMAN PRESCRIPTION DRUG LABEL	4