Prescription drug · NDA

Morphine Sulfate NDC 63323-454

Morphine sulfate 4 mg/mL · Injection, Solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)63323-454Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63323-0454Add 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
63323-454-016332304540125 VIAL, SINGLE-DOSE in 1 BOX (63323-454-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-454-00)Marketed from Apr 10, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 4 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 204223
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 63323-454_f5584ff8-f338-4d14-b29e-e37b3978b747SPL ID f5584ff8-f338-4d14-b29e-e37b3978b747SPL set ID 582f42e5-444e-4246-af8c-e7e28097c69aRxCUI 1731993, 1732006, 1732011, 1732136, 2003714UNII X3P646A2J0UPC 0363323454005, 0363323451004
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N463323045401 followed by a unit qualifier and the quantity

Package 63323-0454-01. 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 Injection is indicated for the management of 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 [see Warnings and Precautions ( 5.1 )], and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 204223

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

FDA NDC Directory listings under NDA 204223
ProductStrengthForm · routeLabelerProduct NDC
Morphine SulfateMorphine sulfate 5 mg/mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi, USA LLC76045-006
Morphine SulfateMorphine sulfate 2 mg/mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi, USA LLC76045-004
Morphine SulfateMorphine sulfate 4 mg/mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi, USA LLC76045-005
Morphine SulfateMorphine sulfate 8 mg/mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi, USA LLC76045-007
Morphine SulfateMorphine sulfate 10 mg/mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi, USA LLC76045-008
Morphine SulfateMorphine sulfate 1 mg/.5mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi, USA LLC76045-238
Morphine SulfateMorphine sulfate 10 mg/mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi USA, LLC63323-451
Morphine SulfateMorphine sulfate 2 mg/mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi USA, LLC63323-452
Morphine SulfateMorphine sulfate 5 mg/mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi USA, LLC63323-455
Morphine SulfateMorphine sulfate 8 mg/mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi USA, LLC63323-458

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Morphine Sulfate NDC 63323-454 | Med-Code