What is NDC 0555-0635?

0555-0635 is the product NDC for Danazol, Danazol 200 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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 0555-0635 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0555-0635Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00555-0635Add 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
0555-0635-02	00555063502	100 CAPSULE in 1 BOTTLE (0555-0635-02)Marketed from Aug 9, 1996
0555-0635-09	00555063509	60 CAPSULE in 1 BOTTLE (0555-0635-09)Marketed from Aug 9, 1996

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 — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074582
Marketing start: Aug 9, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 0555-0635_012ba27f-5410-4461-bc8a-72004ac311a6SPL ID 012ba27f-5410-4461-bc8a-72004ac311a6SPL set ID e19acee5-ff33-45a5-bbbf-801756bc59b4RxCUI 197554, 197555, 197556UNII N29QWW3BUO
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

N400555063502 followed by a unit qualifier and the quantity

Package 00555-0635-02. 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 1, 2022. 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 0555-0635

What is NDC 0555-0635?: 0555-0635 is the product NDC for Danazol, Danazol 200 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 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?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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	Lannett Company, Inc.	0527-1392	00527-1392-01
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

Other NDCs under ANDA 074582

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

FDA NDC Directory listings under ANDA 074582
Product	Strength	Form · route	Labeler	Product NDC
Danazol	Danazol 50 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0555-0633
Danazol	Danazol 100 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0555-0634