Methylphenidate Hydrochloride

In shortageOrange BookUNIISPLATC N06BA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerLupin Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4338657201
100 TABLET, CHEWABLE in 1 BOTTLE (43386-572-01)

Annotations

UNII (FDA Substance ID)

4B3SC438HI

METHYLPHENIDATE HYDROCHLORIDE

RxCUI 203188

Orange Book

A204115

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Methylphenidate Film, Extended Release

Raw payload (JSON)

{
  "unii": {
    "unii": "4B3SC438HI",
    "rxcui": "203188",
    "inchikey": "JUMYIBMBTDDLNG-OJERSXHUSA-N;JUMYIBMBTDDLNG-QNTKWALQSA-N",
    "display_name": "METHYLPHENIDATE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f7a7ffd1-bc30-4db8-8391-dddf76acd639": {
      "match": "brand_token",
      "title": "METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS LLC]",
      "spl_version": "8",
      "published_date": "2026-06-01"
    }
  },
  "productid": "43386-572_c9e22f02-1ba0-41b6-ad52-181d18094553",
  "productndc": "43386-572",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "204115",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Feb 25, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Feb 25, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Feb 25, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPHENIDATE HYDROCHLORIDE",
  "shortage_reason": "Methylphenidate Film, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Methylphenidate Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204115",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methylphenidate Hydrochloride",
  "start_marketing_date": "20150406",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06BA04.

Access this data programmatically

Query Methylphenidate Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs