Dextroamphetamine

Product NDC: 27808-085
11-digit product format: 278080085
Labeler code: 27808
Product ID: 27808-085_442f3920-82b4-41ab-b485-24954a2ebddb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dextroamphetamine
Dosage form: SOLUTION
Route: ORAL
Labeler: Cranbury Pharmaceuticals, LLC
Application: ANDA203644
Marketing category: ANDA
Marketing start: 2013-05-31
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: 2026-12-31
Current FDA listing: Yes

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

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
A203644-001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA		2013-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203644-001	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 · 41 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	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203644-001	DEXTROAMPHETAMINE SULFATE	5MG/5ML	SOLUTION / ORAL	AA	2013-05-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A203644-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203644-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203644-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203644-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203644-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203644-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203644-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203644-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203644-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203644-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203644-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203644-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203644-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203644-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203644-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203644-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203644-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203644-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203644-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203644-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203644-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203644-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203644-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203644-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203644-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203644-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203644-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203644-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203644-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203644-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203644-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203644-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203644-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203644-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203644-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203644-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203644-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203644-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203644-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203644-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dextroamphetamine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JJ768O327N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884522	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
7658071e-ee2c-4d23-94ce-1906959ec036	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
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	5	20230426
8170729e-5ba4-46f9-830f-5f0fae5942ce	Product name	1	20230103
2a7aa275-a4ca-44eb-971f-47427a374085	Product name	9	20220615
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27	Product name	5	20190913
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	4	20171211
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
ffdf7f68-0f44-4dd6-a026-336dcb345fc4	Product name	1	20151109
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27808-085-01	Dextroamphetamine	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27808-085-01	ML - Milliliter	27808-085	f51d4926-bbb7-4d55-bb2c-e68d7781bac3	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROAMPHETAMINE SULFATE	ACTIVE INGREDIENT	JJ768O327N	DEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]	2
DEXTROAMPHETAMINE	ACTIVE MOIETY	TZ47U051FI	DEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	DEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]	2
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	DEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEXTROAMPHETAMINE SOLUTION [TRIS PHARMA INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27808-085	DEXTROAMPHETAMINE SOLUTION [CRANBURY PHARMACEUTICALS, LLC]	15	Current NDC, Legacy NDC, 1 package rows	20250328_7658071e-ee2c-4d23-94ce-1906959ec036.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextroamphetamine	DEXTROAMPHETAMINE	Cranbury Pharmaceuticals, LLC	7658071e-ee2c-4d23-94ce-1906959ec036	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203644 application number: ANDA203644 ndc (product): 27808-085
Dextroamphetamine	DEXTROAMPHETAMINE	Bryant Ranch Prepack	76da9845-2ce1-49a5-9bf3-6a550d623172	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203644 application number: ANDA203644

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JJ768O327N	DEXTROAMPHETAMINE SULFATE	51-63-8	DEXTROAMPHETAMINE SULFATE
TZ47U051FI	DEXTROAMPHETAMINE	51-64-9	Dextroamphetamine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884522	dextroamphetamine sulfate 5 MG in 5 mL Oral Solution	PSN	76da9845-2ce1-49a5-9bf3-6a550d623172	102
884522	dextroamphetamine sulfate 1 MG/ML Oral Solution	SCD	76da9845-2ce1-49a5-9bf3-6a550d623172	102
884522	dextroamphetamine sulfate 5 MG per 5 ML Oral Solution	SY	76da9845-2ce1-49a5-9bf3-6a550d623172	102
884522	dextroamphetamine sulfate 5 MG in 5 mL Oral Solution	PSN	7658071e-ee2c-4d23-94ce-1906959ec036	16
884522	dextroamphetamine sulfate 1 MG/ML Oral Solution	SCD	7658071e-ee2c-4d23-94ce-1906959ec036	16
884522	dextroamphetamine sulfate 5 MG per 5 ML Oral Solution	SY	7658071e-ee2c-4d23-94ce-1906959ec036	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27808-085-01	27808008501	473 mL in 1 BOTTLE, PLASTIC (27808-085-01)	473 ml	2013-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dextroamphetamine Sulfate Oral Solution CII, 5 mg/5 mL Rx Only	Bryant Ranch Prepack	2025-05-19	HUMAN PRESCRIPTION DRUG LABEL	102
Dextroamphetamine Sulfate Oral Solution CII, 5 mg/5 mL Rx Only	Cranbury Pharmaceuticals, LLC	2025-05-19	HUMAN PRESCRIPTION DRUG LABEL	16