Prescription drug · ANDA
Morphine Sulfate NDC 0641-6127
Morphine sulfate 10 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6127-25 | 00641612725 | 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-6127-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6127-01)Marketed from Jun 3, 2015 |
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 — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205758
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0641-6127_fb513d10-94f4-45f5-8b30-fa82ef83e4e2SPL ID fb513d10-94f4-45f5-8b30-fa82ef83e4e2SPL set ID 6023606c-150c-40c5-9175-598efe2a56c3RxCUI 1731993, 1732006, 1732011UNII X3P646A2J0UPC 0306416126250, 0306416127257
- 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
N400641612725followed by a unit qualifier and the quantityPackage 00641-6127-25. 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 and persist over the course of therapy [see Warnings and Precautions (5.1) ] , 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.
Other NDCs under ANDA 205758
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Morphine Sulfate | Morphine sulfate 4 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6125 |
| Morphine Sulfate | Morphine sulfate 8 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6126 |
| Morphine Sulfate | Morphine sulfate 4 mg/mL | InjectionIntravenous | Civica, Inc. | 72572-440 |