Home NDC 75834-327-01 Dexmethylphenidate hydrochloride
Product NDC 75834-327
Requested package NDC 75834-327-01
11-digit product format 758340327
Labeler code 75834
Product ID 75834-327_6103914c-da93-4648-9180-e5c439a07bc2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexmethylphenidate hydrochloride
Dosage form TABLET
Route ORAL
Labeler Nivagen Pharmaceuticals, Inc.
Application ANDA209211
Marketing category ANDA
Marketing start 2024-05-03
Substance DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength 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 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19
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 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209211-001 DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG TABLET / ORAL AB 2018-09-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209211-002 DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG TABLET / ORAL AB 2018-09-19 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXMETHYLPHENIDATE HYDROCHLORIDE 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 899518 Internal RxNorm lookup 899548 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 75834-327-01 Dexmethylphenidate hydrochloride 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 75834-327 DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [NIVAGEN PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20240503_638f614c-bf91-4bf6-876f-bf25fa273bc4.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75834-327-01 75834032701 100 TABLET in 1 BOTTLE (75834-327-01) 100 tablet 2024-05-03 No No Current