Amphetamine Sulfate

Product NDC: 69452-227
Requested package NDC: 69452-227-20
11-digit product format: 694520227
Labeler code: 69452
Product ID: 69452-227_9845d365-ee3e-5db9-e053-2a95a90a81db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amphetamine
Dosage form: TABLET
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA212919
Marketing category: ANDA
Marketing start: 2020-01-15
Marketing end: 0000-00-00
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69452-227	69452-227-20	I	Inactivated by FDA		2026-08-07

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A212919-001	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA		2019-11-22
A212919-002	AMPHETAMINE SULFATE	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA		2019-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212919-001	AA
A212919-002	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 · 76 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	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212919-001	AMPHETAMINE SULFATE	5MG	TABLET / ORAL	AA	2019-11-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212919-002	AMPHETAMINE SULFATE	10MG	TABLET / ORAL	AA	2019-11-22	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A212919-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212919-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212919-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212919-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212919-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212919-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212919-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212919-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212919-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212919-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212919-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212919-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212919-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212919-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212919-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212919-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212919-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212919-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212919-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212919-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212919-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212919-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212919-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212919-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212919-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212919-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212919-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212919-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212919-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212919-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212919-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212919-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212919-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212919-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212919-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212919-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212919-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212919-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212919-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212919-002	AA	1	`87673890dc5c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69452-227-20	2025-01-30	C162847	48780-1	2cef2736-9fa4-d83d-e063-dadaa90ab31f	Amphetamine Sulfate Tablets CII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69452-227-20	Amphetamine Sulfate	100 in 1 BOTTLE	TABLET	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-227-20	EA - Each	69452-227	51874430-28ef-470e-a9f9-e1a1b91bcc78	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-227	AMPHETAMINE SULFATE (AMPHETAMINE) TABLET [BIONPHARMA INC.]	1	Legacy NDC, 1 package rows	20200115_828c84a6-a317-4e4d-9521-0c3865ff732f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6DPV8NK46S	AMPHETAMINE SULFATE	60-13-9	AMPHETAMINE SULFATE
CK833KGX7E	AMPHETAMINE	300-62-9	Amphetamine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1600695	amphetamine sulfate 10 MG Oral Tablet	PSN	828c84a6-a317-4e4d-9521-0c3865ff732f	1
884655	amphetamine sulfate 5 MG Oral Tablet	PSN	828c84a6-a317-4e4d-9521-0c3865ff732f	1
1600695	amphetamine sulfate 10 MG Oral Tablet	SCD	828c84a6-a317-4e4d-9521-0c3865ff732f	1
884655	amphetamine sulfate 5 MG Oral Tablet	SCD	828c84a6-a317-4e4d-9521-0c3865ff732f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-227-20	69452022720	100 TABLET in 1 BOTTLE (69452-227-20)	100 tablet	2020-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amphetamine Sulfate Tablets CII Rx only	Bionpharma Inc. \| CoreRx Inc.	2019-11-26	HUMAN PRESCRIPTION DRUG LABEL	1