Prescription drug · ANDA
Zenchent FE (Norethindrone and ethinyl estradiol) NDC 69238-1581
Kit · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1581-3 | 6923815810369238158103 | 3 BLISTER PACK in 1 CARTON (69238-1581-3) / 1 KIT in 1 BLISTER PACKMarketed from Jun 29, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Zenchent FE
- Generic name (nonproprietary)
- norethindrone and ethinyl estradiol
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078892
- Marketing start
- Listing expires
- Identifiers
- Product ID 69238-1581_44ee7abe-a384-4540-82e8-55c44c05863eSPL ID 44ee7abe-a384-4540-82e8-55c44c05863eSPL set ID 17a9750b-e1b0-4293-992d-195b2eb9ea11RxCUI 433718, 1095223, 1095224, 1483558UPC 0365162158199, 0369238158199
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
N469238158103followed by a unit qualifier and the quantityPackage 69238-1581-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy. • Zenchent Fe, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 69238-1581
- What is NDC 69238-1581?
- 69238-1581 is the product NDC for Zenchent FE kit, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zenchent FE (Norethindrone and Ethinyl Estradiol).
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zenchent FE?
- 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.