What is NDC 42291-478?

42291-478 is the product NDC for Etonogestrel and Ethinyl Estradiol Vaginal, Ethinyl estradiol .015 mg/d; Etonogestrel .12 mg/d ring, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Ethinyl estradiol, Etonogestrel.

AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Etonogestrel and Ethinyl Estradiol Vaginal?

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.

NDC 42291-478

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0478Add 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
42291-478-03	4229104780342291047803	3 POUCH in 1 CARTON (42291-478-03) / 21 d in 1 POUCH (42291-478-11)Marketed from Sep 21, 2023

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): Etonogestrel and Ethinyl Estradiol Vaginal
Generic name (nonproprietary): etonogestrel and ethinyl estradiol vaginal
Active ingredients: Ethinyl estradiol — .015 mg/dEtonogestrel — .12 mg/d
Dosage form: Ring
Route: Vaginal
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211157
Marketing start: Sep 21, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 42291-478_5b184d90-a1fd-bd56-e063-6294a90aa607SPL ID 5b184d90-a1fd-bd56-e063-6294a90aa607SPL set ID 05e172aa-e18a-427b-e063-6294a90ae22fRxCUI 1367436UNII 423D2T571U, 304GTH6RNH
Pharmacologic class: Estrogen; Progestin

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

N442291047803 followed by a unit qualifier and the quantity

Package 42291-0478-03. 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 Sep 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

FOR VAGINAL USE ONLY Etonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy. Etonogestrel and ethinyl estradiol vaginal ring is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-478

What is NDC 42291-478?: 42291-478 is the product NDC for Etonogestrel and Ethinyl Estradiol Vaginal, Ethinyl estradiol .015 mg/d; Etonogestrel .12 mg/d ring, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Etonogestrel and Ethinyl Estradiol Vaginal.
What is the active ingredient?: Ethinyl estradiol, Etonogestrel.
Who is the labeler?: AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Etonogestrel and Ethinyl Estradiol Vaginal?: 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.

Other NDCs under ANDA 211157

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

FDA NDC Directory listings under ANDA 211157
Product	Strength	Form · route	Labeler	Product NDC
EnilloRingetonogestrel and ethinyl estradiol vaginal	Ethinyl estradiol .015 mg/d; Etonogestrel .12 mg/d	RingVaginal	Xiromed, LLC	70700-156
Etonogestrel and Ethinyl Estradiol Vaginal Ring	Ethinyl estradiol .015 mg/d; Etonogestrel .12 mg/d	RingVaginal	Northstar Rx LLC	16714-029

Etonogestrel and Ethinyl Estradiol Vaginal NDC 42291-478