Home NDC 59630-750 Methylin
Product NDC 59630-750
11-digit product format 596300750
Labeler code 59630
Product ID 59630-750_64c7c464-4ef5-401a-ab3c-c0443e5e31a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylphenidate Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler SHIONOGI INC.
Application NDA021419
Marketing category NDA
Marketing start 2002-12-19
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 2026-12-31
Current FDA listing Yes 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…
Additional Listing Data#
Finished product Yes
Brand name base Methylin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091133 Internal RxNorm lookup 1091135 Internal RxNorm lookup 1091341 Internal RxNorm lookup 1091343 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 59630-750-50 Methylin 500 mL in 1 BOTTLE SOLUTION 500 32
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59630-750 METHYLIN (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [SHIONOGI INC.] 32 Current NDC, Legacy NDC, 1 package rows 20240724_9e3c22d9-71d9-46a7-b315-8021c94c4bec.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 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 ndc (product): 59630-750
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59630-750-50 59630075050 500 mL in 1 BOTTLE (59630-750-50) 500 ml 2002-12-19 0000-00-00 No No Current