Prescription drug · NDA
Cortenema (Hydrocortisone) NDC 62559-111
Hydrocortisone 100 mg/60mL · Enema · Rectal · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-111-07 | 62559011107 | 7 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) / 60 mL in 1 BOTTLE, UNIT-DOSEMarketed from Aug 10, 2012 | |
| 62559-111-11 | 62559011111 | 1 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
N462559011107followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hydrocortisone | Hydrocortisone 100 mg/60mL | EnemaRectal | ANI Pharmaceuticals, Inc. | 62559-138 |