Morphine Sulfate

In shortageOrange BookUNIISPLATC N02AA51

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC

CountryUS (United States)

ATC codeN02AA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0115128101
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-01)
ndc11
0115128103
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-03)
ndc11
0115128108
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-08)

Annotations

UNII (FDA Substance ID)

X3P646A2J0

MORPHINE SULFATE

RxCUI 30236

Orange Book

A200411

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Morphine Sulfate Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "X3P646A2J0",
    "rxcui": "30236",
    "inchikey": "GRVOTVYEFDAHCL-RTSZDRIGSA-N",
    "display_name": "MORPHINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc": {
      "match": "brand_token",
      "title": "MORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]",
      "spl_version": "9",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0115-1281_b2330bfc-8b32-421e-ade5-2076ee23cebb",
  "productndc": "0115-1281",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "200411",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Apr 12, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Apr 12, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Apr 12, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG",
        "product_no": "004",
        "approval_date": "Apr 12, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "80MG",
        "product_no": "005",
        "approval_date": "Apr 12, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "006",
        "approval_date": "Apr 12, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "40MG",
        "product_no": "007",
        "approval_date": "Jul 25, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MORPHINE SULFATE",
  "shortage_reason": "Morphine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Morphine Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA200411",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MORPHINE SULFATE",
  "start_marketing_date": "20160412",
  "active_numerator_strength": "80"
}

Related drugs

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