Prescription drug · NDA

Morphine Sulfate NDC 0054-0238

Morphine sulfate 20 mg/5mL · Solution · Oral · Hikma Pharmaceuticals USA Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)0054-0238Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00054-0238Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0054-0238-4900054023849100 mL in 1 BOTTLE (0054-0238-49)Marketed from Mar 17, 2008
0054-0238-6300054023863500 mL in 1 BOTTLE (0054-0238-63)Marketed from Mar 17, 2008

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Morphine Sulfate
Generic name (nonproprietary)
morphine sulfate
Active ingredients
Morphine sulfate — 20 mg/5mL
Dosage form
Solution
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022195
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 0054-0238_1bfdbb7c-d06a-4010-82f9-189b59a2f18dSPL ID 1bfdbb7c-d06a-4010-82f9-189b59a2f18dSPL set ID ca359246-4674-4b32-b8b2-673d32b7112fRxCUI 892589, 892625, 894780UNII X3P646A2J0UPC 0300540238636, 0300540237493
Pharmacologic class
Opioid Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400054023849 followed by a unit qualifier and the quantity

Package 00054-0238-49. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Morphine Sulfate Oral Solution 2 mg/mL and 4 mg/mL is indicated for the management of: • adults with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. • pediatric patients 2 years of age and older with pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use : Because of the risks of addiction, abuse, misuse, overdose, and dea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022195

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022195
ProductStrengthForm · routeLabelerProduct NDC
Morphine SulfateMorphine sulfate 10 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-0904
Morphine SulfateMorphine sulfate 100 mg/5mLSolutionOralHikma Pharmaceuticals USA Inc.0054-0517
Morphine SulfateMorphine sulfate 10 mg/5mLSolutionOralPrecision Dose Inc.68094-001
Morphine SulfateMorphine sulfate 10 mg/5mLSolutionOralHikma Pharmaceuticals USA Inc.0054-0237
Morphine SulfateMorphine sulfate 100 mg/5mLSolutionOralPrecision Dose, Inc.68094-045
Morphine SulfateMorphine sulfate 100 mg/5mLSolutionOralPrecision Dose, Inc.68094-056
Morphine SulfateMorphine sulfate 10 mg/5mLSolutionOralAmerican Health Packaging60687-760
Morphine SulfateMorphine sulfate 100 mg/5mLSolutionOralPrecision Dose, Inc.68094-156
Morphine SulfateMorphine sulfate 100 mg/5mLSolutionOralPrecision Dose, Inc.68094-356
Morphine SulfateMorphine sulfate 100 mg/5mLSolutionOralPrecision Dose, Inc.68094-556

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Morphine Sulfate NDC 0054-0238 | Med-Code