Home NDC 10702-075 METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE
Product NDC 10702-075
11-digit product format 107020075
Labeler code 10702
Product ID 10702-075_40950048-0e42-4661-e063-6394a90a2bb1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methylphenidate hydrochloride extended release
Dosage form TABLET
Route ORAL
Labeler KVK-Tech, Inc.
Application ANDA207488
Marketing category ANDA
Marketing start 2015-06-09
Substance METHYLPHENIDATE 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 1 .
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 A207488-001 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE / ORAL AB 2015-06-09 A207488-002 METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE / ORAL AB RS 2015-06-09
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.
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 2026-08-01 22:54:32 2026-06 A207488-001 METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE / ORAL AB 2015-06-09 a50c72e98297…2026-08-01 22:54:32 2026-06 A207488-002 METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE / ORAL AB RS 2015-06-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A207488-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A207488-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPHENIDATE 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 4B3SC438HI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091145 Internal RxNorm lookup 1091225 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 10702-075-01 2024-02-16 C162847 48780-1 1030e365-473e-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 10702-075-01 2024-02-16 C162847 48780-1 1030e365-473e-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 10702-075-06 2024-02-16 C162847 48780-1 1030e365-473e-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 10702-075-06 2024-02-16 C162847 48780-1 1030e365-473e-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 10702-075-01 2024-01-30 C162847 48780-1 1030e365-473e-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 10702-075-01 2024-01-30 C162847 48780-1 1030e365-473e-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 10702-075-06 2024-01-30 C162847 48780-1 1030e365-473e-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 10702-075-06 2024-01-30 C162847 48780-1 1030e365-473e-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10702-075-01 METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE 100 in 1 BOTTLE TABLET 100 14 10702-075-06 METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE 60 in 1 BOTTLE TABLET 60 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10702-075 METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE TABLET [KVK-TECH, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20240621_be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d.zip
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 10702-075-01 10702007501 100 TABLET in 1 BOTTLE (10702-075-01) 100 tablet 2015-06-09 0000-00-00 No No Current 10702-075-06 10702007506 60 TABLET in 1 BOTTLE (10702-075-06) 60 tablet 2015-06-09 0000-00-00 No No Current