AMPHETAMINE SULFATE

Product NDC: 43547-457
Requested package NDC: 43547-457-10
11-digit product format: 435470457
Labeler code: 43547
Product ID: 43547-457_b11d796e-584c-49a4-9f05-b499f5cd0f5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amphetamine sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA211861
Marketing category: ANDA
Marketing start: 2020-04-02
Substance: AMPHETAMINE SULFATE
Active strength: 5 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211861-001	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA		2020-03-11
A211861-002	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA		2020-03-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211861-001	AA
A211861-002	AA

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 2 · 78 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	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211861-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2020-03-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211861-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2020-03-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211861-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211861-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211861-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211861-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211861-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211861-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211861-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211861-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211861-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211861-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211861-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211861-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211861-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211861-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211861-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211861-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211861-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211861-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211861-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211861-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211861-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211861-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211861-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211861-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211861-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211861-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211861-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211861-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211861-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211861-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211861-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211861-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211861-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211861-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211861-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211861-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211861-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211861-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211861-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211861-002	AA	1	`bb7c543d1eb4…`

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: AMPHETAMINE SULFATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMPHETAMINE SULFATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6DPV8NK46S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884655	Internal RxNorm lookup
1600695	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
89c5b52f-3c2a-41d5-8624-9ee51c512c72	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
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
57953747-955c-4dd8-9164-49d8ea877eae	Product name	1	20171113
fcc7ea58-a369-4e91-b092-5cde9ac2669f	Product name	1	20160224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43547-457-10	AMPHETAMINE SULFATE	100 in 1 BOTTLE	TABLET	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-457-10	EA - Each	43547-457	972325b6-945b-464c-85e3-f83ef3a38d34	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-457	AMPHETAMINE SULFATE TABLET [SOLCO HEALTHCARE US, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20231013_89c5b52f-3c2a-41d5-8624-9ee51c512c72.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Solco Healthcare US, LLC	89c5b52f-3c2a-41d5-8624-9ee51c512c72	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211861 application number: ANDA211861 ndc (package): 43547-457-10 ndc (product): 43547-457 ndc11 (package): 43547045710
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	ad4ce013-331b-4359-898f-bac97d64874f	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211861 application number: ANDA211861
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	7f16dd18-bf30-41ef-8981-932da5df0951	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211861 application number: ANDA211861
AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	Bryant Ranch Prepack	8f9341fc-4b95-4556-a51a-ea972fa6fccc	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211861 application number: ANDA211861

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6DPV8NK46S	AMPHETAMINE SULFATE	60-13-9	AMPHETAMINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884655	amphetamine sulfate 5 MG Oral Tablet	PSN	ad4ce013-331b-4359-898f-bac97d64874f	100
884655	amphetamine sulfate 5 MG Oral Tablet	SCD	ad4ce013-331b-4359-898f-bac97d64874f	100
1600695	amphetamine sulfate 10 MG Oral Tablet	PSN	89c5b52f-3c2a-41d5-8624-9ee51c512c72	8
884655	amphetamine sulfate 5 MG Oral Tablet	PSN	89c5b52f-3c2a-41d5-8624-9ee51c512c72	8
1600695	amphetamine sulfate 10 MG Oral Tablet	SCD	89c5b52f-3c2a-41d5-8624-9ee51c512c72	8
884655	amphetamine sulfate 5 MG Oral Tablet	SCD	89c5b52f-3c2a-41d5-8624-9ee51c512c72	8
1600695	amphetamine sulfate 10 MG Oral Tablet	PSN	8f9341fc-4b95-4556-a51a-ea972fa6fccc	3
884655	amphetamine sulfate 5 MG Oral Tablet	PSN	8f9341fc-4b95-4556-a51a-ea972fa6fccc	3
1600695	amphetamine sulfate 10 MG Oral Tablet	SCD	8f9341fc-4b95-4556-a51a-ea972fa6fccc	3
884655	amphetamine sulfate 5 MG Oral Tablet	SCD	8f9341fc-4b95-4556-a51a-ea972fa6fccc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-457-10	43547045710	100 TABLET in 1 BOTTLE (43547-457-10)	100 tablet	2020-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amphetamine Sulfate Tablets, USP, CII	Solco Healthcare US, LLC \| Prinston Pharmaceutical Inc. \| Generics Bidco ⅡLLC	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	8
Amphetamine Sulfate Tablets, USP, CII	Bryant Ranch Prepack	2024-01-25	HUMAN PRESCRIPTION DRUG LABEL	100
Amphetamine Sulfate Tablets, USP, CII	Bryant Ranch Prepack	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	3