cotempla xr-odt (70165-200)

Drug Facts

Product Profile

Brand Name cotempla xr-odt

Generic Name methylphenidate

Labeler neos therapeutics brands, llc

Dosage Form TABLET, ORALLY DISINTEGRATING

Routes

ORAL

Active Ingredients

methylphenidate 17.3 mg/1

Manufacturer

Neos Therapeutics Brands, LLC

Identifiers & Regulatory

Product NDC 70165-200

Product ID 70165-200_3f8e1342-96a7-1d02-e063-6394a90a3903

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA205489

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2017-06-20

Pharmacologic Class

Established (EPC)

central nervous system stimulant [epc]

Physiologic Effect

central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70165200

Hyphenated Format 70165-200

Supplemental Identifiers

RxCUI

1926840 1926847 1926849 1926851 1926853 1926855

UNII

207ZZ9QZ49

NUI

N0000175739 N0000175729

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cotempla xr-odt (source: ndc)

Generic Name methylphenidate (source: ndc)

Application Number NDA205489 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

17.3 mg/1

source: ndc

Packaging

5 BLISTER PACK in 1 CARTON (70165-200-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

source: ndc

Packages (1)

70165-200-30 5 BLISTER PACK in 1 CARTON (70165-200-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

methylphenidate (17.3 mg/1)

Linked Drug Pages (1)

Cotempla XR-ODT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3f8e1342-96a7-1d02-e063-6394a90a3903", "openfda": {"nui": ["N0000175739", "N0000175729"], "unii": ["207ZZ9QZ49"], "rxcui": ["1926840", "1926847", "1926849", "1926851", "1926853", "1926855"], "spl_set_id": ["33f70f58-c871-42c8-8adb-345caeafefcd"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]"], "manufacturer_name": ["Neos Therapeutics Brands, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 CARTON (70165-200-30)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "70165-200-30", "marketing_start_date": "20170620"}], "brand_name": "Cotempla XR-ODT", "product_id": "70165-200_3f8e1342-96a7-1d02-e063-6394a90a3903", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "70165-200", "dea_schedule": "CII", "generic_name": "Methylphenidate", "labeler_name": "Neos Therapeutics Brands, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cotempla XR-ODT", "active_ingredients": [{"name": "METHYLPHENIDATE", "strength": "17.3 mg/1"}], "application_number": "NDA205489", "marketing_category": "NDA", "marketing_start_date": "20170620", "listing_expiration_date": "20261231"}