Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate ER

Product NDC: 49884-841
11-digit product format: 498840841
Labeler code: 49884
Product ID: 49884-841_1412a044-59ea-421e-b4b6-2d435d0d8d55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate ER
Dosage form: CAPSULE
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA206159
Marketing category: ANDA
Marketing start: 2019-06-25
Marketing end: 0000-00-00
Substance: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength: 4 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 Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
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	49884-841		D	Discontinued by firm		2026-08-03
excluded package	package	49884-841	49884-841-01	D	Discontinued by firm		2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-841-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-841-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-841-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-841-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-841-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-841-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-841-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-841-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-841-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49884-841-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49884-841-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49884-841-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49884-841-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		Y	Unknown FDA exclusion code: Y	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	49884-841-01	Y	Unknown FDA exclusion code: Y	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	49884-841-01	Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`

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	Approval date
A206159-001	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	2019-05-31
A206159-002	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	2019-05-31
A206159-003	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	2019-05-31
A206159-004	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	2019-05-31
A206159-005	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	2019-05-31
A206159-006	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	2019-05-31

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206159-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206159-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206159-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206159-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206159-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206159-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206159-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206159-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206159-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206159-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206159-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206159-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206159-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206159-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206159-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206159-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206159-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206159-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206159-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206159-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206159-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206159-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206159-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206159-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206159-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206159-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206159-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206159-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206159-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206159-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206159-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206159-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206159-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206159-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206159-005	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	6.25MG;6.25MG;6.25MG;6.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206159-006	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	7.5MG;7.5MG;7.5MG;7.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206159-001	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	1.25MG;1.25MG;1.25MG;1.25MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206159-002	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	2.5MG;2.5MG;2.5MG;2.5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206159-003	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	3.75MG;3.75MG;3.75MG;3.75MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206159-004	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	5MG;5MG;5MG;5MG	CAPSULE, EXTENDED RELEASE / ORAL	2019-05-31	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206159-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206159-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206159-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206159-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206159-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206159-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206159-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206159-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206159-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206159-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206159-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206159-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206159-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206159-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206159-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206159-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206159-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206159-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206159-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206159-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206159-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206159-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206159-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206159-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206159-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206159-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206159-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206159-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206159-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206159-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206159-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206159-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206159-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206159-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206159-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206159-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206159-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206159-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206159-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206159-004	AB	1	`87673890dc5c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49884-841-01	2022-09-27	C162847	48780-1	e4f33bdf-ab6f-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXTROAMPHETAMINE SACCHARATE , AMPHETAMINE ASPARTATE MONOHYDRATE , DEXTROAMPHETAMINE SULFATE , AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES. DEXTROAMPHETAMINE saccharate, AMPHETAMINE aspartate monohydrate, DEXTROAMPHETAMINE sulfate, AMPHETAMINE s
49884-841-01	2022-07-29	C162847	48780-1	e4f33bdf-ab6f-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXTROAMPHETAMINE SACCHARATE , AMPHETAMINE ASPARTATE MONOHYDRATE , DEXTROAMPHETAMINE SULFATE , AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES. DEXTROAMPHETAMINE saccharate, AMPHETAMINE aspartate monohydrate, DEXTROAMPHETAMINE sulfate, AMPHETAMINE s

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-841-01	EA - Each	49884-841	fc5cd974-f122-4201-91af-dab8ee50865f	1	2019-08-06

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-841-01	49884084101	100 CAPSULE in 1 BOTTLE (49884-841-01)	100 capsule	2019-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXTROAMPHETAMINE SACCHARATE	Bryant Ranch Prepack	2023-03-02	HUMAN PRESCRIPTION DRUG LABEL	103
DEXTROAMPHETAMINE SACCHARATE	Par Pharmaceutical, Inc.	2022-04-29	HUMAN PRESCRIPTION DRUG LABEL	15