Prescription drug · ANDA
Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate NDC 69238-1686
Kit · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1686-3 | 6923816860369238168603 | 5 CARTON in 1 TRAY (69238-1686-3) / 1 BLISTER PACK in 1 CARTON (69238-1686-6) / 1 KIT in 1 BLISTER PACKMarketed from Jul 26, 2021 |
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)
- Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol, and ferrous fumarate
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214292
- Marketing start
- Listing expires
- Identifiers
- Product ID 69238-1686_90aeeab4-172c-4f1d-932e-5f543c066dbaSPL ID 90aeeab4-172c-4f1d-932e-5f543c066dbaSPL set ID e145ebc7-b6c0-474b-a712-c6f3b2342998RxCUI 1421459, 1421460, 1421461UPC 0369238168631
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
N469238168603followed by a unit qualifier and the quantityPackage 69238-1686-03. 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)
Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. -------------INDICATIONS AND USAGE------------- Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules are a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy (1) Norethindrone acetate an…
Excerpt only. Read the full label for complete information.
About NDC 69238-1686
- What is NDC 69238-1686?
- 69238-1686 is the product NDC for Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate kit, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate.
- Who is the labeler?
- Amneal Pharmaceuticals 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 Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate?
- 3 other product NDCs are listed under this name. See all Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate | — | Kit | Mylan Pharmaceuticals Inc. | 0378-7303 | 00378-7303-53 |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | — | Kit | Glenmark Pharmaceuticals Inc., USA | 68462-849 | 68462-0849-29 |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | — | Kit | Amneal Pharmaceuticals NY LLC | 60219-1031 | 60219-1031-07 |