dextroamphetamine sulfate

Product NDC: 46672-646
11-digit product format: 466720646
Labeler code: 46672
Product ID: 46672-646_9c6f58aa-cf9b-72e1-e053-2995a90ab123
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextroamphetamine sulfate
Dosage form: SOLUTION
Route: ORAL
Labeler: Mikart, LLC
Application: ANDA040776
Marketing category: ANDA
Marketing start: 2008-01-29
Marketing end: 0000-00-00
Substance: DEXTROAMPHETAMINE SULFATE
Active strength: 5 mg/5mL
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040776-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040776-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040776-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-01-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A040776-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040776-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040776-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040776-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040776-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040776-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040776-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040776-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040776-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040776-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040776-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040776-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040776-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040776-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040776-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040776-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040776-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040776-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040776-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040776-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040776-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040776-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040776-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040776-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040776-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040776-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040776-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040776-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040776-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040776-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040776-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040776-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040776-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040776-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040776-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040776-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040776-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040776-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040776-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040776-001	AA	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROAMPHETAMINE SULFATE	ACTIVE INGREDIENT	JJ768O327N	DEXTROAMPHETAMINE SULFATE SOLUTION [MIKART, INC.]	2
DEXTROAMPHETAMINE	ACTIVE MOIETY	TZ47U051FI	DEXTROAMPHETAMINE SULFATE SOLUTION [MIKART, INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DEXTROAMPHETAMINE SULFATE SOLUTION [MIKART, INC.]	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	DEXTROAMPHETAMINE SULFATE SOLUTION [MIKART, INC.]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DEXTROAMPHETAMINE SULFATE SOLUTION [MIKART, INC.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DEXTROAMPHETAMINE SULFATE SOLUTION [MIKART, INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DEXTROAMPHETAMINE SULFATE SOLUTION [MIKART, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROAMPHETAMINE SULFATE SOLUTION [MIKART, INC.]	2

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCENTRA	DEXTROAMPHETAMINE SULFATE	INDEPENDENCE PHARMACEUTICALS, LLC	1548cce2-fb6b-4f17-8a3b-868933f6c9d6	2025-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040776 application number: ANDA040776
Dextroamphetamine Sulfate	DEXTROAMPHETAMINE SULFATE	Prasco Laboratories	94674695-aa8a-3150-e053-2995a90a445f	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040776 application number: ANDA040776

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
46672-646-16	46672064616	473 mL in 1 BOTTLE, PLASTIC (46672-646-16)	473 ml	2008-01-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRESCRIBING INFORMATION Dextroamphetamine Sulfate Oral Solution, 5 mg/5 mL CII	Mikart, LLC	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	4