Prescription drug · ANDA
Danazol NDC 0527-1368
Danazol 100 mg/1 · Capsule · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-1368-01 | 00527136801 | 100 CAPSULE in 1 BOTTLE (0527-1368-01)Marketed from Apr 19, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Danazol
- Generic name (nonproprietary)
- danazol
- Active ingredients
- Danazol — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078214
- Marketing start
- Listing expires
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 0527-1368_399a377e-237d-4939-ad70-805ebd30a1c9SPL ID 399a377e-237d-4939-ad70-805ebd30a1c9SPL set ID f2c9b713-aafc-49ca-866e-334d9b5c2e2dRxCUI 197554, 197555, 197556UNII N29QWW3BUOUPC 0305271368010, 0305271369017, 0305271392015
- Pharmacologic class
- Androgen
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400527136801followed by a unit qualifier and the quantityPackage 00527-1368-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 078214
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.