NDC codes

FDA NDC Directory
Product NDC (as listed)16477-202Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16477-0202Add 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 NDC11-digit (billing)PackageCopy
16477-202-12164770202121647702021212 SUPPOSITORY in 1 BOX (16477-202-12)Marketed from Aug 2, 2021

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 — 30 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 16477-202_47d761e2-d5ae-52a0-e063-6394a90a94e1SPL ID 47d761e2-d5ae-52a0-e063-6394a90a94e1SPL set ID d625764a-6171-4802-9bc0-95e5785b8b7dRxCUI 1291085, 1674200UNII 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

N416477020212 followed by a unit qualifier and the quantity

Package 16477-0202-12. 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.

Full label on DailyMed (opens in a new tab)

About NDC 16477-202

What is NDC 16477-202?
16477-202 is the product NDC for Hemmorex-HC (hydrocortisone acetate), Hydrocortisone acetate 30 mg/1 suppository, listed with the FDA by Laser Pharmaceuticals, LLC. It has 1 package NDC, 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hemmorex-HC NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hemmorex-HChydrocortisone acetateHydrocortisone acetate 25 mg/1SuppositoryRectalLaser Pharmaceuticals, LLC16477-20116477-0201-1216477-0201-2416477-0201-99

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