Home NDC 0406-3005 Methylphenidate HCl
Product NDC 0406-3005
11-digit product format 004063005
Labeler code 0406
Product ID 0406-3005_01cb123a-736f-4e5e-834a-f7a48fd2e33c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler SpecGx LLC
Application NDA021419
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-08-01
Marketing end 2021-01-31
Substance METHYLPHENIDATE HYDROCHLORIDE
Active strength 5 mg/5mL
Pharmacologic classes Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule CII
NDC exclude flag No
Listing certified through 0000-00-00
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 · 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 0406-3005-50 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 0406-3005-50 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 0406-3005-50 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 0406-3005-50 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 0406-3005-50 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 0406-3005-50 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 0406-3005-50 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 0406-3005-50 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 0406-3005-50 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 0406-3005-50 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 0406-3005-50 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 0406-3005-50 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021419-001 METHYLIN METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 N021419-002 METHYLIN METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 70 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021419-001 7691880 2024-10-07 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021419-002 7691880 2024-10-07 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021419-001 7691880 2024-10-07 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021419-002 7691880 2024-10-07 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021419-001 7691880 2024-10-07 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021419-002 7691880 2024-10-07 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021419-001 7691880 2024-10-07 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021419-002 7691880 2024-10-07 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021419-001 7691880 2024-10-07 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021419-002 7691880 2024-10-07 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021419-001 7691880 2024-10-07 Drug product 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021419-002 7691880 2024-10-07 Drug product 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021419-001 7691880 2024-10-07 Drug product 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021419-002 7691880 2024-10-07 Drug product 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021419-001 7691880 2024-10-07 Drug product 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021419-002 7691880 2024-10-07 Drug product 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021419-001 7691880 2024-10-07 Drug product 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021419-002 7691880 2024-10-07 Drug product 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021419-001 7691880 2024-10-07 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021419-002 7691880 2024-10-07 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021419-001 7691880 2024-10-07 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021419-002 7691880 2024-10-07 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021419-001 7691880 2024-10-07 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021419-002 7691880 2024-10-07 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021419-001 7691880 2024-10-07 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021419-002 7691880 2024-10-07 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021419-001 7691880 2024-10-07 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021419-002 7691880 2024-10-07 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021419-001 7691880 2024-10-07 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021419-002 7691880 2024-10-07 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021419-001 7691880 2024-10-07 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021419-002 7691880 2024-10-07 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021419-001 7691880 2024-10-07 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021419-002 7691880 2024-10-07 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021419-001 7691880 2024-10-07 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021419-002 7691880 2024-10-07 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021419-001 7691880 2024-10-07 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021419-002 7691880 2024-10-07 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021419-001 7691880 2024-10-07 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021419-002 7691880 2024-10-07 Drug product 3f01610625f2…
DailyMed Socrata Ingredients# 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 Methylin METHYLPHENIDATE HYDROCHLORIDE SHIONOGI INC. 9e3c22d9-71d9-46a7-b315-8021c94c4bec 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021419 application number: NDA021419