What is NDC 0169-5176?

0169-5176 is the product NDC for Vagifem (estradiol), Estradiol 10 ug/1 insert, listed with the FDA by Novo Nordisk. It has 3 package NDCs, shown above in 10- and 11-digit form.

Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Vagifem?

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.

Vagifem NDC 0169-5176 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0169-5176Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00169-5176Add 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
0169-5176-03	00169517603	8 APPLICATOR in 1 CARTON (0169-5176-03) / 1 INSERT in 1 APPLICATORMarketed from Jan 11, 2010
0169-5176-04	00169517604	18 APPLICATOR in 1 CARTON (0169-5176-04) / 1 INSERT in 1 APPLICATORMarketed from Jan 11, 2010
0169-5176-99	00169517699	6 APPLICATOR in 1 CARTON (0169-5176-99) / 1 INSERT in 1 APPLICATORMarketed from Jan 11, 2010

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): Vagifem
Generic name (nonproprietary): estradiol
Active ingredients: Estradiol — 10 ug/1
Dosage form: Insert
Route: Vaginal
Labeler: Novo NordiskNDC labeler code 0169
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020908
Marketing start: Jan 11, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 0169-5176_9564f4b5-dbf2-429a-b058-f240e296cec9SPL ID 9564f4b5-dbf2-429a-b058-f240e296cec9SPL set ID e5ad3cf6-dd96-4e64-af21-c1eee38d0b88RxCUI 884707, 884709UNII 4TI98Z838E
Pharmacologic class: Estrogen

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400169517603 followed by a unit qualifier and the quantity

Package 00169-5176-03. 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 Feb 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

• Vagifem is an estrogen indicated for the treatment of atrophic vaginitis due to menopause ( 1.1 ). 1.1 Treatment of Atrophic Vaginitis due to Menopause

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0169-5176

What is NDC 0169-5176?: 0169-5176 is the product NDC for Vagifem (estradiol), Estradiol 10 ug/1 insert, listed with the FDA by Novo Nordisk. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Vagifem (Estradiol).
What is the active ingredient?: Estradiol.
Who is the labeler?: Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Vagifem?: 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.

Vagifem (Estradiol) NDC 0169-5176