Prescription drug · ANDA
Danazol NDC 71205-861
Danazol 100 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-861-00 | 71205086100 | 100 CAPSULE in 1 BOTTLE (71205-861-00)Marketed from Apr 1, 2022 | |
| 71205-861-30 | 71205086130 | 30 CAPSULE in 1 BOTTLE (71205-861-30)Marketed from Apr 1, 2022 | |
| 71205-861-55 | 71205086155 | 500 CAPSULE in 1 BOTTLE (71205-861-55)Marketed from Apr 1, 2022 | |
| 71205-861-60 | 71205086160 | 60 CAPSULE in 1 BOTTLE (71205-861-60)Marketed from Apr 1, 2022 | |
| 71205-861-72 | 71205086172 | 120 CAPSULE in 1 BOTTLE (71205-861-72)Marketed from Apr 1, 2022 | |
| 71205-861-90 | 71205086190 | 90 CAPSULE in 1 BOTTLE (71205-861-90)Marketed from Apr 1, 2022 |
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)
- Danazol
- Generic name (nonproprietary)
- danazol
- Active ingredients
- Danazol — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 71205-861_9e103cf9-f075-48ba-8913-2e44f9442781SPL ID 9e103cf9-f075-48ba-8913-2e44f9442781SPL set ID 9e103cf9-f075-48ba-8913-2e44f9442781RxCUI 197554, 197555UNII N29QWW3BUOUPC 0371205861308
- 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
N471205086100followed by a unit qualifier and the quantityPackage 71205-0861-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Hereditary Angioedema. Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078214
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.