Dexmethylphenidate hydrochloride

Product NDC: 57664-628
11-digit product format: 576640628
Labeler code: 57664
Product ID: 57664-628_dfada2f5-18f1-4d93-96ad-7cbca3e712e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dexmethylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA206734
Marketing category: ANDA
Marketing start: 2021-11-05
Marketing end: 0000-00-00
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	57664-628		D	Discontinued by firm		2026-10-15
excluded package	package	57664-628	57664-628-88	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-628-88	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-628-88	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-628-88	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-628-88	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-628-88	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-628-88	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-628-88	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-628-88	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-628-88	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05
A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05

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 · 288 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206734-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-11-05	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 6 · 232 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206734-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206734-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206734-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206734-004	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206734-005	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206734-006	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206734-007	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206734-008	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206734-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206734-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206734-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206734-004	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206734-005	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206734-006	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206734-007	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206734-008	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206734-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206734-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206734-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206734-004	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206734-005	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206734-006	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206734-007	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206734-008	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206734-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A206734-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A206734-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A206734-004	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A206734-005	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A206734-006	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A206734-007	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A206734-008	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206734-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206734-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206734-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206734-004	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206734-005	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206734-006	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206734-007	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206734-008	AB	1	`3bdfa0b2c4d7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-628-88	EA - Each	57664-628	86070dc8-df73-4273-a221-d1f098903296	1	2022-02-07

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-628-88	57664062888	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-628-88)	2021-11-05	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.	2024-01-16	HUMAN PRESCRIPTION DRUG LABEL	8