Home NDC 53014-582 Metadate CD
Product NDC 53014-582
11-digit product format 530140582
Labeler code 53014
Product ID 53014-582_bb9a02a4-3803-482d-970d-0f27f3b6f452
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methylphenidate hydrochloride
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Unither Manufacturing, LLC
Application NDA021259
Marketing category NDA
Marketing start 2006-03-21
Marketing end 0000-00-00
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 40 mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule CII
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53014-582-07 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53014-582-07 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53014-582-07 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53014-582-07 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53014-582-07 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53014-582-07 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53014-582-07 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53014-582-07 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53014-582-07 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53014-582-07 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53014-582-07 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53014-582-07 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53014-582-07 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021259-001 METADATE CD METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2001-04-03 N021259-002 METADATE CD METHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-06-19 N021259-003 METADATE CD METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-05-27 N021259-004 METADATE CD METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 N021259-005 METADATE CD METHYLPHENIDATE HYDROCHLORIDE 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 N021259-006 METADATE CD METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD, RS 2006-02-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 7 · 264 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N021259-001 METADATE CD 20MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2001-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021259-002 METADATE CD 30MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-06-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021259-003 METADATE CD 10MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-05-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021259-004 METADATE CD 40MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021259-005 METADATE CD 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021259-006 METADATE CD 60MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD, RS 2006-02-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021259-001 METADATE CD 20MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2001-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021259-002 METADATE CD 30MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-06-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021259-003 METADATE CD 10MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-05-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021259-004 METADATE CD 40MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021259-005 METADATE CD 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021259-006 METADATE CD 60MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD, RS 2006-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021259-001 METADATE CD 20MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2001-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021259-002 METADATE CD 30MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-06-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021259-003 METADATE CD 10MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021259-004 METADATE CD 40MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021259-005 METADATE CD 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021259-006 METADATE CD 60MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD, RS 2006-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021259-001 METADATE CD 20MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2001-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021259-002 METADATE CD 30MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021259-003 METADATE CD 10MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021259-004 METADATE CD 40MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021259-005 METADATE CD 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021259-006 METADATE CD 60MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD, RS 2006-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021259-001 METADATE CD 20MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2001-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021259-002 METADATE CD 30MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021259-003 METADATE CD 10MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021259-004 METADATE CD 40MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021259-005 METADATE CD 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021259-006 METADATE CD 60MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD, RS 2006-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021259-001 METADATE CD 20MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2001-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021259-002 METADATE CD 30MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021259-003 METADATE CD 10MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021259-004 METADATE CD 40MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021259-005 METADATE CD 50MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021259-006 METADATE CD 60MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD, RS 2006-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021259-001 METADATE CD 20MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2001-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021259-002 METADATE CD 30MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021259-003 METADATE CD 10MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2003-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021259-004 METADATE CD 40MG CAPSULE, EXTENDED RELEASE / ORAL AB2 RLD 2006-02-19 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 264 observed states.
Observed Orange Book patent history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded methylphenidate hydrochloride ACTIVE INGREDIENT 4B3SC438HI METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 methylphenidate ACTIVE MOIETY 207ZZ9QZ49 METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 dibutyl sebacate INACTIVE INGREDIENT 4W5IH7FLNY METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 ethylcelluloses INACTIVE INGREDIENT 7Z8S9VYZ4B METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 Ferric Oxide Yellow INACTIVE INGREDIENT EX438O2MRT METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 gelatin INACTIVE INGREDIENT 2G86QN327L METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 povidones INACTIVE INGREDIENT FZ989GH94E METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC] 13
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 METADATE CD METHYLPHENIDATE HYDROCHLORIDE Aytu BioPharma, Inc. be59f8b4-7842-42cc-9559-bfa747f0baa5 2025-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021259 application number: NDA021259