Prescription drug · ANDA
Morphine Sulfate NDC 76329-1912
Morphine sulfate 1 mg/30mL · Injection · Intravenous · International Medication Systems, Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76329-1912-1 | 76329191201 | 10 VIAL in 1 PACKAGE (76329-1912-1) / 30 mL in 1 VIAL (76329-1912-0)Marketed from Jan 20, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 1 mg/30mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202861
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 76329-1912_99799101-d92b-485b-93ec-f2b5a2e5ca26SPL ID 99799101-d92b-485b-93ec-f2b5a2e5ca26SPL set ID 1034467f-d436-4b87-a902-c7e8885daa8aUNII 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.
- NDC on a medical claim
N476329191201followed by a unit qualifier and the quantityPackage 76329-1912-01. 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 use of an opioid analgesic by Patient Controlled Analgesia (PCA), and for which alternative treatments are inadequate. Limitations of Use Preservative-free Morphine Sulfate Injection is for administration via a compatible Alaris ® infusion device. Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require use of an opioid analgesic by Patient-Controlled Analgesia (PCA), and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Only for use with a compatible Alaris ® infusion device.
Excerpt only. Read the full label for complete information.