Dexmethylphenidate hydrochloride

Product NDC: 57664-379
11-digit product format: 576640379
Labeler code: 57664
Product ID: 57664-379_0d0cbfc3-ae27-b481-e063-6394a90a917c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmethylphenidate hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA201231
Marketing category: ANDA
Marketing start: 2013-09-26
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
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 42.

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	Approval date
A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24
A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24
A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201231-001	AB
A201231-002	AB
A201231-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201231-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201231-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201231-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2015-09-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201231-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201231-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201231-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201231-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201231-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201231-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201231-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201231-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201231-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201231-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201231-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201231-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201231-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201231-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201231-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201231-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201231-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201231-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201231-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201231-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201231-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201231-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201231-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201231-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201231-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201231-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201231-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201231-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201231-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201231-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201231-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201231-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201231-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201231-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201231-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201231-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201231-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201231-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201231-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201231-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1678OK0E08	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
899518	Internal RxNorm lookup
899548	Internal RxNorm lookup
899557	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
987b4983-1edc-40f1-adc9-724747080969	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ff349b0-f325-4585-9c0d-7dc58eb1bc1b	Product name	1	20210818
7d5b6b15-5a1e-e1e5-992d-90d0701572ad	Product name	9	20210511
ccfbb2ac-2915-4b21-1d79-8a93f773e70f	Product name	9	20200714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57664-379-08	Dexmethylphenidate hydrochloride	100 in 1 BOTTLE	TABLET	100	13
57664-379-13	Dexmethylphenidate hydrochloride	500 in 1 BOTTLE	TABLET	500	13
57664-379-18	Dexmethylphenidate hydrochloride	1000 in 1 BOTTLE	TABLET	1000	13
57664-379-83	Dexmethylphenidate hydrochloride	30 in 1 BOTTLE	TABLET	30	13
57664-379-88	Dexmethylphenidate hydrochloride	100 in 1 BOTTLE	TABLET	100	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-379-88	EA - Each	57664-379	dc18d6ef-0c7b-4977-85b1-504f678a569c	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXMETHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	1678OK0E08	DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
DEXMETHYLPHENIDATE	ACTIVE MOIETY	M32RH9MFGP	DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-379	DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13	Current NDC, Legacy NDC, 5 package rows	20240105_987b4983-1edc-40f1-adc9-724747080969.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmethylphenidate hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	987b4983-1edc-40f1-adc9-724747080969	2024-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201231 application number: ANDA201231 ndc (product): 57664-379

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1678OK0E08	DEXMETHYLPHENIDATE HYDROCHLORIDE	19262-68-1	DEXMETHYLPHENIDATE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
899548	dexmethylphenidate HCl 10 MG Oral Tablet	PSN	987b4983-1edc-40f1-adc9-724747080969	13
899557	dexmethylphenidate HCl 2.5 MG Oral Tablet	PSN	987b4983-1edc-40f1-adc9-724747080969	13
899518	dexmethylphenidate HCl 5 MG Oral Tablet	PSN	987b4983-1edc-40f1-adc9-724747080969	13
899548	dexmethylphenidate hydrochloride 10 MG Oral Tablet	SCD	987b4983-1edc-40f1-adc9-724747080969	13
899557	dexmethylphenidate hydrochloride 2.5 MG Oral Tablet	SCD	987b4983-1edc-40f1-adc9-724747080969	13
899518	dexmethylphenidate hydrochloride 5 MG Oral Tablet	SCD	987b4983-1edc-40f1-adc9-724747080969	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-379-08	57664037908	100 TABLET in 1 BOTTLE (57664-379-08)	100 tablet	2013-09-26	0000-00-00	No	No	Current
57664-379-13	57664037913	500 TABLET in 1 BOTTLE (57664-379-13)	500 tablet	2013-09-26	0000-00-00	No	No	Current
57664-379-18	57664037918	1000 TABLET in 1 BOTTLE (57664-379-18)	1000 tablet	2013-09-26	0000-00-00	No	No	Current
57664-379-83	57664037983	30 TABLET in 1 BOTTLE (57664-379-83)	30 tablet	2013-09-26	0000-00-00	No	No	Current
57664-379-88	57664037988	100 TABLET in 1 BOTTLE (57664-379-88)	100 tablet	2013-09-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmethylphenidate hydrochloride	Sun Pharmaceutical Industries, Inc. \| Ohm Laboratories Inc.	2024-01-02	HUMAN PRESCRIPTION DRUG LABEL	13
Dexmethylphenidate hydrochloride	Bryant Ranch Prepack	2020-07-20	HUMAN PRESCRIPTION DRUG LABEL	2