Prescription drug · ANDA
Etonogestrel and Ethinyl Estradiol NDC 0093-7679
Etonogestrel .12 mg/d; Ethinyl estradiol .015 mg/d · Insert, Extended release · Vaginal · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-7679-02 | 0009376790200093767902 | 3 POUCH in 1 CARTON (0093-7679-02) / 21 d in 1 POUCH (0093-7679-01)Marketed from Jan 19, 2021 |
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)
- Etonogestrel and Ethinyl Estradiol
- Generic name (nonproprietary)
- etonogestrel and ethinyl estradiol
- Active ingredients
- Etonogestrel — .12 mg/dEthinyl estradiol — .015 mg/d
- Dosage form
- Insert, Extended release
- Route
- Vaginal
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204305
- Marketing start
- Marketing end
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0093-7679_d0827dbf-9df5-4438-a0c2-92d7d593e71cSPL ID d0827dbf-9df5-4438-a0c2-92d7d593e71cSPL set ID a8cc104a-d522-49ad-af54-2f312b829b61RxCUI 1367436UNII 304GTH6RNH, 423D2T571UUPC 0300937679028
- 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
N400093767902followed by a unit qualifier and the quantityPackage 00093-7679-02. 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 . 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.
About NDC 0093-7679
- What is NDC 0093-7679?
- 0093-7679 is the product NDC for Etonogestrel and Ethinyl Estradiol, Etonogestrel .12 mg/d; Ethinyl estradiol .015 mg/d insert, extended release, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Etonogestrel and Ethinyl Estradiol.
- What is the active ingredient?
- Etonogestrel, Ethinyl estradiol.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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?
- 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.