Dexmethylphenidate Hydrochloride

Product NDC: 0378-4084
11-digit product format: 003784084
Labeler code: 0378
Product ID: 0378-4084_f6f0cc2d-acc9-4db2-b0bb-6d9872d5ba3d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexmethylphenidate hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA202580
Marketing category: ANDA
Marketing start: 2013-11-18
Marketing end: 0000-00-00
Substance: DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0378-4084		D	Discontinued by firm		2026-10-21
excluded package	package	0378-4084	0378-4084-01	D	Discontinued by firm		2026-10-21

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 · 24 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	0378-4084-01	`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	0378-4084-01	`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	0378-4084-01	`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	0378-4084-01	`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	0378-4084-01	`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	0378-4084-01	`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	0378-4084-01	`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	0378-4084-01	`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	0378-4084-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-4084-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-4084-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-4084-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28
A202580-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25
A202580-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25
A202580-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25
A202580-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-12-21
A202580-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-05-04
A202580-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-05-04
A202580-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25

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 · 72 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	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202580-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202580-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202580-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202580-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-12-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202580-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-05-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202580-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-05-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202580-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202580-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202580-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202580-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202580-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202580-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-05-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202580-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-05-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202580-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202580-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202580-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202580-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202580-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202580-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202580-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202580-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2015-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202580-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-08-28	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202580-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202580-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202580-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202580-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202580-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202580-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202580-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202580-001	AB	1	`ea99ee380514…`

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
0378-4084-01	EA - Each	0378-4084	39a2ec96-8be7-4380-ad1d-d4b7c4848443	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXMETHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	1678OK0E08	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
DEXMETHYLPHENIDATE	ACTIVE MOIETY	M32RH9MFGP	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13

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
0378-4084-01	00378408401	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4084-01)	2013-11-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexmethylphenidate Hydrochloride	Mylan Pharmaceuticals Inc.	2019-11-27	HUMAN PRESCRIPTION DRUG LABEL	20