Home NDC 43386-862 Dexmethylphenidate Hydrochloride
Product NDC 43386-862
11-digit product format 433860862
Labeler code 43386
Product ID 43386-862_4d2d72fd-412e-4556-9adc-d4673576a29c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexmethylphenidate Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA204534
Marketing category ANDA
Marketing start 2015-12-04
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
Listing certified through 2026-12-31
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 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04
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 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204534-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-12-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204534-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-12-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204534-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2015-12-04 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dexmethylphenidate Hydrochloride
Listing expiration 2026-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 899518 Internal RxNorm lookup 899548 Internal RxNorm lookup 899557 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 43386-862-01 Dexmethylphenidate Hydrochloride 100 in 1 BOTTLE TABLET 100 7 43386-862-03 Dexmethylphenidate Hydrochloride 30 in 1 BOTTLE TABLET 30 7 43386-862-10 Dexmethylphenidate Hydrochloride 1000 in 1 BOTTLE TABLET 1000 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-862 DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS,INC.] 7 Current NDC, Legacy NDC, 3 package rows 20240131_a61932ef-c2b6-4363-a21d-1f0358f317b6.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.
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 43386-862-01 43386086201 100 TABLET in 1 BOTTLE (43386-862-01) 100 tablet 2015-12-04 0000-00-00 No No Current 43386-862-03 43386086203 30 TABLET in 1 BOTTLE (43386-862-03) 30 tablet 2015-12-04 0000-00-00 No No Current 43386-862-10 43386086210 1000 TABLET in 1 BOTTLE (43386-862-10) 1000 tablet 2015-12-04 0000-00-00 No No Current