What is NDC 0527-1392?

0527-1392 is the product NDC for Danazol, Danazol 50 mg/1 capsule, listed with the FDA by Lannett Company, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lannett Company, Inc., NDC labeler code 0527. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Danazol NDC 0527-1392 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-1392Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-1392Add 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
0527-1392-01	0052713920100527139201	100 CAPSULE in 1 BOTTLE (0527-1392-01)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 — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Lannett Company, Inc.NDC labeler code 0527
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078214
Marketing start: Apr 19, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 0527-1392_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

N400527139201 followed by a unit qualifier and the quantity

Package 00527-1392-01. 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

Current FDA label (SPL), effective Apr 30, 2020. 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 0527-1392

What is NDC 0527-1392?: 0527-1392 is the product NDC for Danazol, Danazol 50 mg/1 capsule, listed with the FDA by Lannett Company, Inc.. It has 1 package NDC, 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?: Lannett Company, Inc., NDC labeler code 0527. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Danazol	Danazol 100 mg/1	CapsuleOral	Lannett Company, Inc.	0527-1368	00527-1368-01
Danazol	Danazol 50 mg/1	CapsuleOral	Chartwell RX, LLC.	62135-475	62135-0475-60
Danazol	Danazol 100 mg/1	CapsuleOral	Chartwell RX, LLC.	62135-476	62135-0476-60
Danazol	Danazol 100 mg/1	CapsuleOral	Proficient Rx LP	71205-861	71205-0861-0071205-0861-3071205-0861-55+3 more
Danazol	Danazol 200 mg/1	CapsuleOral	Lannett Company, Inc.	0527-1369	00527-1369-0100527-1369-06
Danazol	Danazol 200 mg/1	CapsuleOral	Chartwell RX, LLC.	62135-477	62135-0477-60
Danazol	Danazol 200 mg/1	CapsuleOral	Proficient Rx LP	71205-862	71205-0862-0071205-0862-3071205-0862-55+3 more
Danazol	Danazol 50 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0555-0633	00555-0633-02
Danazol	Danazol 100 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0555-0634	00555-0634-02
Danazol	Danazol 200 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0555-0635	00555-0635-0200555-0635-09

Other NDCs under ANDA 078214

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

FDA NDC Directory listings under ANDA 078214
Product	Strength	Form · route	Labeler	Product NDC
Danazol	Danazol 100 mg/1	CapsuleOral	Lannett Company, Inc.	0527-1368
Danazol	Danazol 100 mg/1	CapsuleOral	Proficient Rx LP	71205-861