DEXEDRINE

Product NDC: 64896-674
11-digit product format: 648960674
Labeler code: 64896
Product ID: 64896-674_d5d5a976-872f-4849-b222-1fb433511511
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dextroamphetamine sulfate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: NDA017078
Marketing category: NDA
Marketing start: 1976-08-02
Substance: DEXTROAMPHETAMINE SULFATE
Active strength: 10 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N017078-001	DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982
N017078-002	DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982
N017078-003	DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N017078-001	AB
N017078-002	AB
N017078-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017078-001	DEXEDRINE SPANSULE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-002	DEXEDRINE SPANSULE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-003	DEXEDRINE SPANSULE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-001	DEXEDRINE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-002	DEXEDRINE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-003	DEXEDRINE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-001	DEXEDRINE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-002	DEXEDRINE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-003	DEXEDRINE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017078-001	DEXEDRINE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017078-002	DEXEDRINE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017078-003	DEXEDRINE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017078-001	DEXEDRINE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N017078-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017078-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017078-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017078-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017078-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017078-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017078-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017078-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017078-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017078-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017078-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017078-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017078-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017078-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017078-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017078-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017078-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017078-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017078-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: DEXEDRINE
Brand name suffix: SPANSULE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE SULFATE	10 mg/1

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884520	Internal RxNorm lookup
884528	Internal RxNorm lookup
884532	Internal RxNorm lookup
884534	Internal RxNorm lookup
884535	Internal RxNorm lookup
884537	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
cc717b9b-22ea-4c60-a1d4-ee38a40bce78	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
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27	Product name	5	20190913
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	4	20171211
ffdf7f68-0f44-4dd6-a026-336dcb345fc4	Product name	1	20151109

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64896-674-10	DEXEDRINESPANSULE	1 in 1 CARTON	CAPSULE, EXTENDED RELEASE	1		15
64896-674-10	DEXEDRINESPANSULE	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64896-674-10	EA - Each	64896-674	a92a247f-93a7-4899-80c1-c4361f645550	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64896-674	DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	10	Current NDC, Legacy NDC, 2 package rows	20231026_cc717b9b-22ea-4c60-a1d4-ee38a40bce78.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
DEXEDRINE SPANSULE	DEXTROAMPHETAMINE SULFATE	Amneal Pharmaceuticals LLC	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017078 application number: NDA017078 ndc (product): 64896-674
Dextroamphetamine Sulfate Extended-Release	DEXTROAMPHETAMINE SULFATE	Amneal Pharmaceuticals of New York LLC	2ec5c30f-4eb8-48a5-83c4-236450413464	2023-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017078 application number: NDA017078

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JJ768O327N	DEXTROAMPHETAMINE SULFATE	51-63-8	DEXTROAMPHETAMINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884534	Dexedrine 15 MG Extended Release Oral Capsule	PSN	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884528	Dexedrine Spansule 10 MG Extended Release Oral Capsule	PSN	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884537	Dexedrine Spansule 5 MG Extended Release Oral Capsule	PSN	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884520	dextroamphetamine sulfate 10 MG Extended Release Oral Capsule	PSN	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884532	dextroamphetamine sulfate 15 MG Extended Release Oral Capsule	PSN	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884535	dextroamphetamine sulfate 5 MG Extended Release Oral Capsule	PSN	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884528	dextroamphetamine sulfate 10 MG Extended Release Oral Capsule [Dexedrine]	SBD	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884534	dextroamphetamine sulfate 15 MG Extended Release Oral Capsule [Dexedrine]	SBD	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884537	dextroamphetamine sulfate 5 MG Extended Release Oral Capsule [Dexedrine]	SBD	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884520	dextroamphetamine sulfate 10 MG Extended Release Oral Capsule	SCD	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884532	dextroamphetamine sulfate 15 MG Extended Release Oral Capsule	SCD	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884535	dextroamphetamine sulfate 5 MG Extended Release Oral Capsule	SCD	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884528	Dexedrine 10 MG Extended Release Oral Capsule	SY	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884534	Dexedrine 15 MG Extended Release Oral Capsule	SY	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15
884537	Dexedrine 5 MG Extended Release Oral Capsule	SY	cc717b9b-22ea-4c60-a1d4-ee38a40bce78	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64896-674-10	64896067410	1 BOTTLE in 1 CARTON (64896-674-10) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE	1 bottle	1976-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXEDRINE ® (dextroamphetamine sulfate) SPANSULE ® sustained-release capsules, CII Rx Only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC \| AndersonBrecon Inc. \| Catalent Pharma Solutions, LLC	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	15