Danazol NDC 62135-477

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-477Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0477Add 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 NDC	11-digit (billing)	Package	Copy
62135-477-60	62135047760	60 CAPSULE in 1 BOTTLE (62135-477-60)Marketed from Feb 27, 2023

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 — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Chartwell RX, LLC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077246
Marketing start: Sep 28, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 62135-477_241f23e1-4b4b-4adb-e063-6394a90adcc5SPL ID 241f23e1-4b4b-4adb-e063-6394a90adcc5SPL set ID 55ad6325-16f6-4f0c-a1dc-734847052d0bRxCUI 197554, 197555, 197556UNII N29QWW3BUOUPC 0362135477608, 0362135475604, 0362135476601
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

N462135047760 followed by a unit qualifier and the quantity

Package 62135-0477-60. 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 Oct 10, 2024. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077246

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

FDA NDC Directory listings under ANDA 077246
Product	Strength	Form · route	Labeler	Product NDC
Danazol	Danazol 200 mg/1	CapsuleOral	Proficient Rx LP	71205-862
Danazol	Danazol 200 mg/1	CapsuleOral	Lannett Company, Inc.	0527-1369
Danazol	Danazol 50 mg/1	CapsuleOral	Chartwell RX, LLC.	62135-475
Danazol	Danazol 100 mg/1	CapsuleOral	Chartwell RX, LLC.	62135-476