NDC codes

FDA NDC Directory
Product NDC (as listed)62559-111Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62559-0111Add 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
62559-111-07625590111077 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) / 60 mL in 1 BOTTLE, UNIT-DOSEMarketed from Aug 10, 2012
62559-111-11625590111111 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-11) / 60 mL in 1 BOTTLE, UNIT-DOSEMarketed from Aug 10, 2012

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)
Cortenema
Generic name (nonproprietary)
hydrocortisone
Active ingredients
Hydrocortisone — 100 mg/60mL
Dosage form
Enema
Route
Rectal
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 62559
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 016199
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 62559-111_45040499-9056-45bd-9e0f-113b619fc6caSPL ID 45040499-9056-45bd-9e0f-113b619fc6caSPL set ID a307448a-ccc4-41a8-977a-11f28f0bded9RxCUI 102250, 310878UNII WI4X0X7BPJ
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

N462559011107 followed by a unit qualifier and the quantity

Package 62559-0111-07. 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 CORTENEMA® is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62559-111

What is NDC 62559-111?
62559-111 is the product NDC for Cortenema (hydrocortisone), Hydrocortisone 100 mg/60mL enema, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cortenema (Hydrocortisone).
What is the active ingredient?
Hydrocortisone.
Who is the labeler?
ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cortenema?
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.

Other NDCs under NDA 016199

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

FDA NDC Directory listings under NDA 016199
ProductStrengthForm · routeLabelerProduct NDC
HydrocortisoneHydrocortisone 100 mg/60mLEnemaRectalANI Pharmaceuticals, Inc.62559-138

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