NDC codes

FDA NDC Directory
Product NDC (as listed)0054-0236Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00054-0236Add 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
0054-0236-240005402362400054023624100 BLISTER PACK in 1 CARTON (0054-0236-24) / 1 TABLET in 1 BLISTER PACKMarketed from Mar 17, 2008
0054-0236-250005402362500054023625100 TABLET in 1 BOTTLE (0054-0236-25)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 — 30 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022207
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 0054-0236_c89c4f71-eab3-4b74-b098-fcd31d5aa0ddSPL ID c89c4f71-eab3-4b74-b098-fcd31d5aa0ddSPL set ID 3c847554-3b4b-4d24-a145-2ef7e9b83699RxCUI 892582, 892672UNII X3P646A2J0UPC 0300540236250, 0300540235253
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

N400054023624 followed by a unit qualifier and the quantity

Package 00054-0236-24. 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 Tablets are indicated for the management of: • adult and pediatric patients weighing at least 50 kg and above with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. • adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use : Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )], reserve opioid analgesics, including Morphine Sulfate Tablets for use in patients for whom alternative treatment options …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0236

What is NDC 0054-0236?
0054-0236 is the product NDC for Morphine Sulfate, Morphine sulfate 30 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Morphine Sulfate.
What is the active ingredient?
Morphine sulfate.
Who is the labeler?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Morphine Sulfate?
126 other product NDCs are listed under this name. See all Morphine Sulfate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Morphine Sulfate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Morphine SulfateMorphine sulfate 15 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-89360760-0893-60
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-11068000-0110-01
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-11168000-0111-05
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-11268000-0112-05
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-11368000-0113-03
Morphine SulfateMorphine sulfate 20 mg/mLSolutionOralAmerican Health Packaging68000-11468000-0114-03
Morphine SulfateMorphine sulfate 10 mg/5mLSolutionOralAmerican Health Packaging60687-92760687-0927-86
Morphine SulfateMorphine sulfate 10 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-495500121-4955-94
Morphine SulfateMorphine sulfate 100 mg/5mLSolutionOralPrecision Dose, Inc.68094-55668094-0556-58
Morphine SulfateMorphine sulfate 100 mg/5mLSolutionOralPrecision Dose, Inc.68094-15668094-0156-58

All 127 Morphine Sulfate NDCs

Other NDCs under NDA 022207

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

FDA NDC Directory listings under NDA 022207
ProductStrengthForm · routeLabelerProduct NDC
Morphine SulfateMorphine sulfate 15 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-0235

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