NDC codes

FDA NDC Directory
Product NDC (as listed)71205-862Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0862Add 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
71205-862-007120508620071205086200100 CAPSULE in 1 BOTTLE (71205-862-00)Marketed from Apr 1, 2022
71205-862-30712050862307120508623030 CAPSULE in 1 BOTTLE (71205-862-30)Marketed from Apr 1, 2022
71205-862-557120508625571205086255500 CAPSULE in 1 BOTTLE (71205-862-55)Marketed from Apr 1, 2022
71205-862-60712050862607120508626060 CAPSULE in 1 BOTTLE (71205-862-60)Marketed from Apr 1, 2022
71205-862-727120508627271205086272120 CAPSULE in 1 BOTTLE (71205-862-72)Marketed from Apr 1, 2022
71205-862-90712050862907120508629090 CAPSULE in 1 BOTTLE (71205-862-90)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 — 200 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077246
Marketing start
Listing expires
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 71205-862_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

N471205086200 followed by a unit qualifier and the quantity

Package 71205-0862-00. 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.

Full label on DailyMed (opens in a new tab)

About NDC 71205-862

What is NDC 71205-862?
71205-862 is the product NDC for Danazol, Danazol 200 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Danazol.
What is the active ingredient?
Danazol.
Who is the labeler?
Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Danazol?
10 other product NDCs are listed under this name. See all Danazol NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Danazol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DanazolDanazol 100 mg/1CapsuleOralLannett Company, Inc.0527-136800527-1368-01
DanazolDanazol 50 mg/1CapsuleOralLannett Company, Inc.0527-139200527-1392-01
DanazolDanazol 50 mg/1CapsuleOralChartwell RX, LLC.62135-47562135-0475-60
DanazolDanazol 100 mg/1CapsuleOralChartwell RX, LLC.62135-47662135-0476-60
DanazolDanazol 100 mg/1CapsuleOralProficient Rx LP71205-86171205-0861-0071205-0861-3071205-0861-55+3 more
DanazolDanazol 200 mg/1CapsuleOralLannett Company, Inc.0527-136900527-1369-0100527-1369-06
DanazolDanazol 200 mg/1CapsuleOralChartwell RX, LLC.62135-47762135-0477-60
DanazolDanazol 50 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0555-063300555-0633-02
DanazolDanazol 100 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0555-063400555-0634-02
DanazolDanazol 200 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0555-063500555-0635-0200555-0635-09

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
ProductStrengthForm · routeLabelerProduct NDC
DanazolDanazol 200 mg/1CapsuleOralLannett Company, Inc.0527-1369
DanazolDanazol 50 mg/1CapsuleOralChartwell RX, LLC.62135-475
DanazolDanazol 100 mg/1CapsuleOralChartwell RX, LLC.62135-476
DanazolDanazol 200 mg/1CapsuleOralChartwell RX, LLC.62135-477

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