Prescription drug · ANDA
Mitigo (Morphine sulfate) NDC 66794-160
Morphine sulfate 200 mg/20mL · Injection · Epidural, Intrathecal · Piramal Critical Care, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66794-160-02 | 6679401600266794016002 | 1 mL in 1 VIAL, SINGLE-USE (66794-160-02)Marketed from Feb 25, 2019 |
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)
- Mitigo
- Generic name (nonproprietary)
- morphine sulfate
- Active ingredients
- Morphine sulfate — 200 mg/20mL
- Dosage form
- Injection
- Route
- Epidural, Intrathecal
- Labeler
- Piramal Critical Care, Inc.NDC labeler code 66794
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204393
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 66794-160_495a6a51-d35d-2b96-e063-6394a90ac5f3SPL ID 495a6a51-d35d-2b96-e063-6394a90ac5f3SPL set ID 728f3d83-9a63-0c1f-e053-2a91aa0ac7dbRxCUI 1731522, 1731998, 2055307, 2055311UNII 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.
- NDC on a medical claim
N466794016002followed by a unit qualifier and the quantityPackage 66794-0160-02. 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)
MITIGO ® is for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which less invasive means of controlling pain are inadequate. Limitations of Use Not for single-dose intravenous, intramuscular, or subcutaneous administration due to the risk of overdose. Not for single-dose neuraxial injection because MITIGO ® is too concentrated for accurate delivery of the smaller doses used in this setting. MITIGO ® is an opioid agonist, for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intrac…
Excerpt only. Read the full label for complete information.
About NDC 66794-160
- What is NDC 66794-160?
- 66794-160 is the product NDC for Mitigo (morphine sulfate), Morphine sulfate 200 mg/20mL injection, listed with the FDA by Piramal Critical Care, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mitigo (Morphine Sulfate).
- What is the active ingredient?
- Morphine sulfate.
- Who is the labeler?
- Piramal Critical Care, Inc., NDC labeler code 66794. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mitigo?
- 1 other product NDC are listed under this name. See all Mitigo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mitigo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mitigomorphine sulfate | Morphine sulfate 500 mg/20mL | InjectionEpidural, Intrathecal | Piramal Critical Care, Inc. | 66794-162 | 66794-0162-02 |
Other NDCs under ANDA 204393
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 |
|---|---|---|---|---|
| Mitigomorphine sulfate | Morphine sulfate 500 mg/20mL | InjectionEpidural, Intrathecal | Piramal Critical Care, Inc. | 66794-162 |