Prescription drug · UNAPPROVED DRUG OTHER
Hemmorex-HC (Hydrocortisone acetate) NDC 16477-201
Hydrocortisone acetate 25 mg/1 · Suppository · Rectal · Laser Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16477-201-12 | 1647702011216477020112 | 2 BLISTER PACK in 1 BOX (16477-201-12) / 6 SUPPOSITORY in 1 BLISTER PACKMarketed from Nov 12, 2013 | |
| 16477-201-24 | 1647702012416477020124 | 4 BLISTER PACK in 1 BOX (16477-201-24) / 6 SUPPOSITORY in 1 BLISTER PACKMarketed from Nov 12, 2013 | |
| 16477-201-99 | 1647702019916477020199 | 100 BLISTER PACK in 1 BOX (16477-201-99) / 1 SUPPOSITORY in 1 BLISTER PACKMarketed from Feb 15, 2025 |
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)
- Hemmorex-HC
- Generic name (nonproprietary)
- hydrocortisone acetate
- Active ingredients
- Hydrocortisone acetate — 25 mg/1
- Dosage form
- Suppository
- Route
- Rectal
- Labeler
- Laser Pharmaceuticals, LLCNDC labeler code 16477
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 16477-201_2c65695c-de02-6fa3-e063-6294a90aee9dSPL ID 2c65695c-de02-6fa3-e063-6294a90aee9dSPL set ID db67f724-c78c-4280-9c2e-6abbaeaef42dRxCUI 1291082, 1674197UNII 3X7931PO74UPC 0316477201124
- 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
N416477020112followed by a unit qualifier and the quantityPackage 16477-0201-12. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE: Hemmorex-HC™ suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (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.
About NDC 16477-201
- What is NDC 16477-201?
- 16477-201 is the product NDC for Hemmorex-HC (hydrocortisone acetate), Hydrocortisone acetate 25 mg/1 suppository, listed with the FDA by Laser Pharmaceuticals, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hemmorex-HC (Hydrocortisone acetate).
- What is the active ingredient?
- Hydrocortisone acetate.
- Who is the labeler?
- Laser Pharmaceuticals, LLC, NDC labeler code 16477. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hemmorex-HC?
- 1 other product NDC are listed under this name. See all Hemmorex-HC NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hemmorex-HC products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hemmorex-HChydrocortisone acetate | Hydrocortisone acetate 30 mg/1 | SuppositoryRectal | Laser Pharmaceuticals, LLC | 16477-202 | 16477-0202-12 |