METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE

In shortageOrange BookUNIISPLATC N06BA04

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

Identification

ManufacturerKVK-Tech, Inc.

CountryUS (United States)

ATC codeN06BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1070207501
100 TABLET in 1 BOTTLE (10702-075-01)
ndc11
1070207506
60 TABLET in 1 BOTTLE (10702-075-06)

Annotations

UNII (FDA Substance ID)

4B3SC438HI

METHYLPHENIDATE HYDROCHLORIDE

RxCUI 203188

Orange Book

A207488

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Methylphenidate Hydrochloride Tablet, 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": "10702-075_40950048-0e42-4661-e063-6394a90a2bb1",
  "productndc": "10702-075",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207488",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 9, 2015"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jun 9, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPHENIDATE HYDROCHLORIDE",
  "shortage_reason": "Methylphenidate Hydrochloride Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207488",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methylphenidate hydrochloride extended release",
  "start_marketing_date": "20150609",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06BA04.

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