Home NDC 0527-4582-37 methylphenidate hydrochloride CD
Product NDC 0527-4582
Requested package NDC 0527-4582-37
11-digit product format 005274582
Labeler code 0527
Product ID 0527-4582_8e987008-a787-4cbd-8775-69e92239de2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methylphenidate hydrochloride
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Lannett Company, LLC
Application NDA021259
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2006-03-21
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 No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base methylphenidate hydrochloride CD
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPHENIDATE HYDROCHLORIDE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4B3SC438HI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1806181 Internal RxNorm lookup 1806187 Internal RxNorm lookup 1806189 Internal RxNorm lookup 1806191 Internal RxNorm lookup 1806193 Internal RxNorm lookup 1806197 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-4582-37 methylphenidate hydrochloride CD 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-4582 METHYLPHENIDATE HYDROCHLORIDE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20220728_e45c75dc-d381-475b-b649-a871c8a36e60.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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0527-4582-37 00527458237 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4582-37) 2006-03-21 0000-00-00 No No Current