Metadate ER

Product NDC: 53014-594
11-digit product format: 530140594
Labeler code: 53014
Product ID: 53014-594_6470b9ad-04b8-4386-b2c3-184518ac6957
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methylphenidate hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Unither Manufacturing, LLC
Application: ANDA089601
Marketing category: ANDA
Marketing start: 1988-06-01
Marketing end: 0000-00-00
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2017-12-31
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	53014-594		I	Inactivated by FDA		2026-08-10
excluded package	package	53014-594	53014-594-07	I	Inactivated by FDA		2026-08-10

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 · 44 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	53014-594-07	`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	53014-594-07	`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	53014-594-07	`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	53014-594-07	`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	53014-594-07	`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	53014-594-07	`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	53014-594-07	`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	53014-594-07	`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	53014-594-07	`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	53014-594-07	`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	53014-594-07	`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	53014-594-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53014-594-07	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53014-594-07	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53014-594-07	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53014-594-07	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53014-594-07	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53014-594-07	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53014-594-07	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53014-594-07	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53014-594-07	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53014-594-07	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A089601-001	METADATE ER	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL			1988-06-01

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089601-001	METADATE ER	20MG	TABLET, EXTENDED RELEASE / ORAL	1988-06-01	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
143536be-f21a-464c-bc5a-163f5c171815	Product name	2	20250626
fd4d0878-dcea-3832-288e-e3bbbbe580ff	Product name	9	20240516
435f0341-cf24-41d5-8fbf-c909821e5596	Product name	1	20230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436	Product name	2	20221216
67aa32c6-44f4-50de-64dd-643e8caf420d	Product name	6	20210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440	Product name	4	20210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8	Product name	1	20200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1	Product name	1	20190828
343a61d5-785d-cc27-a43a-0779da054d88	Product name	3	20190828
7607489b-cd15-3103-f3b1-d4283574d250	Product name	2	20190614
407f0cce-da29-4050-a512-2cabe9e5692d	Product name	9	20190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38e	Product name	2	20190415
190572d9-6c7b-4b40-8172-c1b5f802c20f	Product name	1	20180724
2948856e-f76e-d380-d9ed-b317efafbc98	Product name	5	20180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695	Product name	1	20170803
3317aade-2d6e-f159-9fe6-e8385a825178	Product name	3	20160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3	Product name	1	20160111

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53014-594-07	2019-11-27	C162847	48780-1	9855e2a2-43f5-60a7-e053-dbdaa90a05bd	Metadate ® ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53014-594-07	Metadate ER	100 in 1 BOTTLE	TABLET, 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
53014-594-07	EA - Each	53014-594	10cc93c1-d5cb-4bf3-bd7c-3f0235f14798	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
methylphenidate hydrochloride	ACTIVE INGREDIENT	4B3SC438HI	METADATE ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	9
methylphenidate	ACTIVE MOIETY	207ZZ9QZ49	METADATE ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	9
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	METADATE ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	9
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	METADATE ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	9
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	METADATE ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	9
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	METADATE ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53014-594	METADATE ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	9	Legacy NDC, 1 package rows	20140512_739bbd64-d9e1-4771-967b-a2cd08f4eaf5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE	23655-65-4	METHYLPHENIDATE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1091488	Metadate ER 20 MG 8HR Extended Release Oral Tablet	PSN	739bbd64-d9e1-4771-967b-a2cd08f4eaf5	9
1091225	methylphenidate HCl 20 MG 8HR Extended Release Oral Tablet	PSN	739bbd64-d9e1-4771-967b-a2cd08f4eaf5	9
1091488	8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet [Metadate]	SBD	739bbd64-d9e1-4771-967b-a2cd08f4eaf5	9
1091225	8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet	SCD	739bbd64-d9e1-4771-967b-a2cd08f4eaf5	9
1091488	8 HR Metadate 20 MG Extended Release Oral Tablet	SY	739bbd64-d9e1-4771-967b-a2cd08f4eaf5	9
1091488	Metadate ER 20 MG 8 HR Extended Release Oral Tablet	SY	739bbd64-d9e1-4771-967b-a2cd08f4eaf5	9
1091225	methylphenidate HCl 20 MG 8 HR Extended Release Oral Tablet	SY	739bbd64-d9e1-4771-967b-a2cd08f4eaf5	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53014-594-07	53014059407	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metadate ® ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) CII	Unither Manufacturing, LLC	2014-01-06	HUMAN PRESCRIPTION DRUG LABEL	9