DEXMETHYLPHENIDATE HYDROCHLORIDE

Product NDC: 70010-007
11-digit product format: 700100007
Labeler code: 70010
Product ID: 70010-007_412b7fd8-c12a-36c2-e063-6394a90acae6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA213813
Marketing category: ANDA
Marketing start: 2020-12-01
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength: 20 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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09
A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A213813-001	AB
A213813-002	AB
A213813-003	AB
A213813-004	AB
A213813-005	AB
A213813-006	AB
A213813-007	AB
A213813-008	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 8 · 296 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	A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-09	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 296 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	A213813-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213813-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213813-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213813-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213813-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213813-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213813-008	AB	1	`b8a1b40f171c…`

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	20 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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
899439	Internal RxNorm lookup
899461	Internal RxNorm lookup
899485	Internal RxNorm lookup
899495	Internal RxNorm lookup
899511	Internal RxNorm lookup
1006608	Internal RxNorm lookup
1101926	Internal RxNorm lookup
1101932	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
abe6862b-3cf3-4aad-98ea-05a5fb54ebec	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	Strength	SPL version
70010-007-01	DEXMETHYLPHENIDATE HYDROCHLORIDE	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-007-01	EA - Each	70010-007	912c061a-9e50-415d-b5ea-46656c834835	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-007	DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]	8	Current NDC, Legacy NDC, 1 package rows	20231111_abe6862b-3cf3-4aad-98ea-05a5fb54ebec.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	Granules Pharmaceuticals Inc.	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213813 application number: ANDA213813 ndc (product): 70010-007

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
899439	dexmethylphenidate HCl 10 MG 24HR Extended Release Oral Capsule	PSN	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899461	dexmethylphenidate HCl 15 MG 24HR Extended Release Oral Capsule	PSN	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899485	dexmethylphenidate HCl 20 MG 24HR Extended Release Oral Capsule	PSN	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
1101926	dexmethylphenidate HCl 25 MG 24HR Extended Release Oral Capsule	PSN	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899495	dexmethylphenidate HCl 30 MG 24HR Extended Release Oral Capsule	PSN	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
1101932	dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule	PSN	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
1006608	dexmethylphenidate HCl 40 MG 24HR Extended Release Oral Capsule	PSN	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899511	dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule	PSN	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899439	24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule	SCD	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899461	24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule	SCD	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899485	24 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
1101926	24 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule	SCD	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899495	24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
1101932	24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule	SCD	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
1006608	24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule	SCD	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899511	24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule	SCD	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899439	dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral Capsule	SY	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899461	dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899485	dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral Capsule	SY	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
1101926	dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral Capsule	SY	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899495	dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral Capsule	SY	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
1101932	dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule	SY	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
1006608	dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral Capsule	SY	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9
899511	dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule	SY	abe6862b-3cf3-4aad-98ea-05a5fb54ebec	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70010-007-01	70010000701	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-007-01)	2020-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEXMETHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	9