methylphenidate hydrochloride

Generic: methylphenidate hydrochloride

Labeler: dr.reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylphenidate hydrochloride
Generic Name methylphenidate hydrochloride
Labeler dr.reddys laboratories inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

methylphenidate hydrochloride 36 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-440
Product ID 43598-440_528a86ce-1037-944a-e934-15846984dd73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213473
DEA Schedule cii
Marketing Start 2020-08-20
Marketing End 2026-09-30

Pharmacologic Class

Classes
central nervous system stimulant [epc] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598440
Hyphenated Format 43598-440

Supplemental Identifiers

RxCUI
1091155 1091170 1091185 1091210
UNII
4B3SC438HI

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 methylphenidate hydrochloride (source: ndc)
Generic Name methylphenidate hydrochloride (source: ndc)
Application Number ANDA213473 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 36 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-440-01)
source: ndc

Packages (1)

43598-440-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-440-01)

Ingredients (1)

methylphenidate hydrochloride (36 mg/1)

Linked Drug Pages (1)

Methylphenidate Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "528a86ce-1037-944a-e934-15846984dd73", "openfda": {"unii": ["4B3SC438HI"], "rxcui": ["1091155", "1091170", "1091185", "1091210"], "spl_set_id": ["7124df7e-6273-a68d-6e35-dc06122d8686"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-440-01)", "package_ndc": "43598-440-01", "marketing_end_date": "20260930", "marketing_start_date": "20200820"}], "brand_name": "Methylphenidate Hydrochloride", "product_id": "43598-440_528a86ce-1037-944a-e934-15846984dd73", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]"], "product_ndc": "43598-440", "dea_schedule": "CII", "generic_name": "Methylphenidate Hydrochloride", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylphenidate Hydrochloride", "active_ingredients": [{"name": "METHYLPHENIDATE HYDROCHLORIDE", "strength": "36 mg/1"}], "application_number": "ANDA213473", "marketing_category": "ANDA", "marketing_end_date": "20260930", "marketing_start_date": "20200820"}