Home NDC 66758-250 Focalin
Product NDC 66758-250
11-digit product format 667580250
Labeler code 66758
Product ID 66758-250_b5989bf2-41d3-4bd9-82aa-d89923911cd1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dexmethylphenidate hydrochloride
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc
Application NDA021278
Marketing category NDA
Marketing start 2001-11-30
Marketing end 2027-09-30
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 129 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 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021278-001 FOCALIN 2.5MG TABLET / ORAL AB RLD 2001-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021278-002 FOCALIN 5MG TABLET / ORAL AB RLD 2001-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021278-003 FOCALIN 10MG TABLET / ORAL AB RLD, RS 2001-11-13 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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 Focalin Active Ingredients# Ingredient, Strength table Ingredient Strength DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1678OK0E08 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 899518 Internal RxNorm lookup 899519 Internal RxNorm lookup 899548 Internal RxNorm lookup 899549 Internal RxNorm lookup 899557 Internal RxNorm lookup 899559 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 66758-250-01 Focalin 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66758-250 FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE) TABLET [SANDOZ INC] 1 Current NDC, 1 package rows 20240711_2016f5c2-95d2-4655-af65-c588c2bf5e6d.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 ndc (product): 66758-250
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 66758-250-01 66758025001 100 TABLET in 1 BOTTLE (66758-250-01) 100 tablet 2024-08-16 2027-07-31 No No Historical