FDA.reportPublic FDA data

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207488-001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2015-06-09
A207488-002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDE20MGTABLET, EXTENDED RELEASE / ORALABRS2015-06-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207488-001AB
A207488-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207488-001METHYLPHENIDATE HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALAB2015-06-09a50c72e98297…
2026-08-01 22:54:322026-06A207488-002METHYLPHENIDATE HYDROCHLORIDE20MGTABLET, EXTENDED RELEASE / ORALABRS2015-06-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207488-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A207488-002AB1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEKVK-Tech, Inc.be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207488
application number: ANDA207488
ndc (product): 10702-075

Additional Listing Data#

Finished product
Yes
Brand name base
METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4B3SC438HIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091145Internal RxNorm lookup
1091225Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
be8580bc-0eb2-4eb6-a4cc-4ebbeb33424dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-075-012024-02-16C16284748780-11030e365-473e-111a-e063-dadaa90a10e2These 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
10702-075-012024-02-16C16284748780-11030e365-473e-111a-e063-dadaa90a10e2These 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
10702-075-062024-02-16C16284748780-11030e365-473e-111a-e063-dadaa90a10e2These 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
10702-075-062024-02-16C16284748780-11030e365-473e-111a-e063-dadaa90a10e2These 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
10702-075-012024-01-30C16284748780-11030e365-473e-111a-e063-dadaa90a10e2These 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
10702-075-012024-01-30C16284748780-11030e365-473e-111a-e063-dadaa90a10e2These 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
10702-075-062024-01-30C16284748780-11030e365-473e-111a-e063-dadaa90a10e2These 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
10702-075-062024-01-30C16284748780-11030e365-473e-111a-e063-dadaa90a10e2These 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 NDCProductDescriptionFormQuantityStrengthSPL version
10702-075-01METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE100 in 1 BOTTLETABLET10014
10702-075-06METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE60 in 1 BOTTLETABLET6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-075-01EA - Each10702-0753be560b2-19e0-40d3-8fe1-0ce7b430e26a12015-07-20
10702-075-06EA - Each10702-07543d8fcf1-ee63-4b9b-b167-cfdda9d6056512015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE TABLET [KVK-TECH, INC.]5
METHYLPHENIDATEACTIVE MOIETY207ZZ9QZ49METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE TABLET [KVK-TECH, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE TABLET [KVK-TECH, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE TABLET [KVK-TECH, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE TABLET [KVK-TECH, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE TABLET [KVK-TECH, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-075METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE TABLET [KVK-TECH, INC.]13Current NDC, Legacy NDC, 2 package rows20240621_be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091145methylphenidate HCl 10 MG 8HR Extended Release Oral TabletPSNbe8580bc-0eb2-4eb6-a4cc-4ebbeb33424d14
1091225methylphenidate HCl 20 MG 8HR Extended Release Oral TabletPSNbe8580bc-0eb2-4eb6-a4cc-4ebbeb33424d14
10911458 HR methylphenidate hydrochloride 10 MG Extended Release Oral TabletSCDbe8580bc-0eb2-4eb6-a4cc-4ebbeb33424d14
10912258 HR methylphenidate hydrochloride 20 MG Extended Release Oral TabletSCDbe8580bc-0eb2-4eb6-a4cc-4ebbeb33424d14
1091145methylphenidate HCl 10 MG 8 HR Extended Release Oral TabletSYbe8580bc-0eb2-4eb6-a4cc-4ebbeb33424d14
1091225methylphenidate HCl 20 MG 8 HR Extended Release Oral TabletSYbe8580bc-0eb2-4eb6-a4cc-4ebbeb33424d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-075-0110702007501100 TABLET in 1 BOTTLE (10702-075-01) 100 tablet2015-06-090000-00-00NoNoCurrent
10702-075-061070200750660 TABLET in 1 BOTTLE (10702-075-06) 60 tablet2015-06-090000-00-00NoNoCurrent