Prescription drug · NDA

Morphine Sulfate NDC 76045-008

Morphine sulfate 10 mg/mL · Injection, Solution · Intramuscular, Intravenous · Fresenius Kabi, USA LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)76045-008Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76045-0008Add the package segment from the table below.

Product information

Brand name (proprietary)
Morphine Sulfate
Generic name (nonproprietary)
morphine sulfate
Active ingredients
Morphine sulfate — 10 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 76045-008_e61f6eb4-cc71-47d3-b2f6-5e689c773779SPL ID e61f6eb4-cc71-47d3-b2f6-5e689c773779SPL set ID 1f53de80-efc8-4930-b3e3-fba0d026af05RxCUI 894912, 894914, 998212, 998213, 1442790, 2752697UNII X3P646A2J0
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

Product label

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

Indications (excerpt from the label)

Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) 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, 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. ( 1 , 5.1 ) Morphine Sulfate Injection is indicated for the management of pain severe enough to require …

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 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 4 mg/mLInjection, SolutionIntramuscular, IntravenousFresenius Kabi USA, LLC63323-454
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 76045-008 | Med-Code