What is NDC 65649-511?

65649-511 is the product NDC for Proctocort (hydrocortisone acetate), Hydrocortisone acetate 30 mg/1 suppository, listed with the FDA by Salix Pharmaceuticals, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Proctocort (Hydrocortisone acetate).

Salix Pharmaceuticals, Inc, NDC labeler code 65649. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Proctocort?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Proctocort NDC 65649-511 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65649-511Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65649-0511Add 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
65649-511-12	6564905111265649051112	12 SUPPOSITORY in 1 BOX (65649-511-12)Marketed from Jun 1, 2004
65649-511-24	6564905112465649051124	24 SUPPOSITORY in 1 BOX (65649-511-24)Marketed from Jun 1, 2004

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): Proctocort
Generic name (nonproprietary): hydrocortisone acetate
Active ingredients: Hydrocortisone acetate — 30 mg/1
Dosage form: Suppository
Route: Rectal
Labeler: Salix Pharmaceuticals, IncNDC labeler code 65649
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jun 1, 2004
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 65649-511_22516e69-93a6-2892-e063-6394a90ae27bSPL ID 22516e69-93a6-2892-e063-6394a90ae27bSPL set ID a2e1222a-ab91-4382-a210-7dfdd6de1407RxCUI 1291085, 1291092UNII 3X7931PO74
Pharmacologic class: Corticosteroid

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

N465649051112 followed by a unit qualifier and the quantity

Package 65649-0511-12. 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 Sep 17, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Proctocort ® Suppositories are indicated for use in inflamed hemorrhoids, postirradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65649-511

What is NDC 65649-511?: 65649-511 is the product NDC for Proctocort (hydrocortisone acetate), Hydrocortisone acetate 30 mg/1 suppository, listed with the FDA by Salix Pharmaceuticals, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Proctocort (Hydrocortisone acetate).
What is the active ingredient?: Hydrocortisone acetate.
Who is the labeler?: Salix Pharmaceuticals, Inc, NDC labeler code 65649. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Proctocort?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Proctocort (Hydrocortisone acetate) NDC 65649-511