Morphine Sulfate NDC 0574-7116

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-7116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-7116Add 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
0574-7116-12	00574711612	12 PACKET in 1 BOX (0574-7116-12) / 1 SUPPOSITORY in 1 PACKETMarketed from Sep 1, 1990

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 — 30 mg/1
Dosage form: Suppository
Route: Rectal
Labeler: Padagis US LLC
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Sep 1, 1990
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0574-7116_fa18ac09-a625-47aa-8cde-7051dc4d0c49SPL ID fa18ac09-a625-47aa-8cde-7051dc4d0c49SPL set ID 649d731b-962a-45df-b043-7e0781e8a530RxCUI 892516, 892603, 892678, 894807UNII 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

N400574711612 followed by a unit qualifier and the quantity

Package 00574-7116-12. 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 Jul 1, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Morphine sulfate suppositories are indicated for the management of acute and chronic pain severe enough to require and opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve morphine sulfate suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia Morphine sulfate suppositories is an opioid ag…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)