Home NDC 0078-0380 Focalin
Product NDC 0078-0380
11-digit product format 000780380
Labeler code 0078
Product ID 0078-0380_ffb90063-7d7a-4f9e-ace8-19aebacf2e20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexmethylphenidate hydrochloride
Dosage form TABLET
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA021278
Marketing category NDA
Marketing start 2001-11-30
Marketing end 2026-07-31
Substance DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength 2.5 mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule CII
NDC exclude flag No
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0078-0380 0078-0380-05 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021278-001 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB RLD 2001-11-13 N021278-002 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB RLD 2001-11-13 N021278-003 FOCALIN DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB RLD, RS 2001-11-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0380-05 Focalin 100 in 1 BOTTLE TABLET 100 28
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0380 FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 27 Current NDC, Legacy NDC, 1 package rows 20231030_7c552f11-e24a-4d9b-bb8d-be10c928eca8.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 Focalin DEXMETHYLPHENIDATE HYDROCHLORIDE Sandoz Inc 2016f5c2-95d2-4655-af65-c588c2bf5e6d 2024-05-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021278 application number: NDA021278
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 0078-0380-05 00078038005 100 TABLET in 1 BOTTLE (0078-0380-05) 100 tablet 2001-11-30 0000-00-00 No No Current