What is NDC 58604-214?

58604-214 is the product NDC for Addyi (flibanserin), Flibanserin 100 mg/1 tablet, film coated, listed with the FDA by Sprout Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sprout Pharmaceuticals, Inc., NDC labeler code 58604. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Addyi?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Addyi NDC 58604-214 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58604-214Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58604-0214Add 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
58604-214-30	58604021430	1 BOTTLE in 1 CARTON (58604-214-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Aug 18, 2015

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): Addyi
Generic name (nonproprietary): flibanserin
Active ingredients: Flibanserin — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sprout Pharmaceuticals, Inc.NDC labeler code 58604
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022526
Marketing start: Aug 18, 2015
Listing expires: Dec 31, 2026
Other FDA classes: P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 58604-214_1d1d7ef0-7a05-41c3-849f-6f1778863a73SPL ID 1d1d7ef0-7a05-41c3-849f-6f1778863a73SPL set ID 3819daf3-e935-2c53-c527-e1d57922f394RxCUI 1665514, 1666391UNII 37JK4STR6ZUPC 0358604214300

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

N458604021430 followed by a unit qualifier and the quantity

Package 58604-0214-30. 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 Dec 22, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

ADDYI is indicated for the treatment of women less than 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: • A co-existing medical or psychiatric condition, • Problems within the relationship, or • The effects of a medication or other drug substance. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner. Limitations of Use • ADDYI is not indicated in men. • ADDYI is not indicated to enhance sex…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58604-214

What is NDC 58604-214?: 58604-214 is the product NDC for Addyi (flibanserin), Flibanserin 100 mg/1 tablet, film coated, listed with the FDA by Sprout Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Addyi (Flibanserin).
What is the active ingredient?: Flibanserin.
Who is the labeler?: Sprout Pharmaceuticals, Inc., NDC labeler code 58604. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Addyi?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Addyi (Flibanserin) NDC 58604-214