Home NDC 67877-657-05 Dexmethylphenidate Hydrochloride
Product NDC 67877-657
Requested package NDC 67877-657-05
11-digit product format 678770657
Labeler code 67877
Product ID 67877-657_d87ba2c9-5dd1-4038-8149-7ef46c421422
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexmethylphenidate Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA212631
Marketing category ANDA
Marketing start 2019-07-21
Substance DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength 10 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 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19
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 · 126 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 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212631-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2019-07-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212631-003 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2019-07-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212631-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2019-07-19 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 Dexmethylphenidate Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXMETHYLPHENIDATE HYDROCHLORIDE 10 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 67877-657-01 Dexmethylphenidate Hydrochloride 100 in 1 BOTTLE TABLET 100 8 67877-657-05 Dexmethylphenidate Hydrochloride 500 in 1 BOTTLE TABLET 500 8 67877-657-30 Dexmethylphenidate Hydrochloride 30 in 1 BOTTLE TABLET 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-657 DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 8 Current NDC, Legacy NDC, 3 package rows 20240717_830df993-db01-40df-beef-90af6b86f561.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 67877-657-05 67877065705 500 TABLET in 1 BOTTLE (67877-657-05) 500 tablet 2019-07-21 0000-00-00 No No Current