Mitigo (morphine sulfate) NDC 66794-160

NDC codes

FDA NDC Directory

Product NDC (as listed)66794-160Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66794-0160Add 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 NDC	11-digit (billing)	Package	Copy
66794-160-02	66794016002	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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204393
Marketing start: Feb 25, 2019
Listing expires: Dec 31, 2027
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

N466794016002 followed by a unit qualifier and the quantity

Package 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 Feb 19, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204393

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

FDA NDC Directory listings under ANDA 204393
Product	Strength	Form · route	Labeler	Product NDC
Mitigomorphine sulfate	Morphine sulfate 500 mg/20mL	InjectionEpidural, Intrathecal	Piramal Critical Care, Inc.	66794-162