Home DailyMed 3abe798b-0f71-44be-a135-99103370d534 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:32:54 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021419-001 METHYLIN 5MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021419-002 METHYLIN 10MG/5ML SOLUTION / ORAL AA RLD, RS 2002-12-19 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.