Prescription drug · ANDA
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate NDC 60219-1031
Kit · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1031-7 | 6021910310760219103107 | 3 BLISTER PACK in 1 CARTON (60219-1031-7) / 1 KIT in 1 BLISTER PACK (60219-1031-6)Marketed from Sep 21, 2017 |
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
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 60219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207514
- Marketing start
- Listing expires
- Identifiers
- Product ID 60219-1031_ae13db8f-27e2-420a-b909-99d0347e6286SPL ID ae13db8f-27e2-420a-b909-99d0347e6286SPL set ID d4fa03d8-0ae0-497f-ba4e-76f03fd7a3abRxCUI 259176, 1358762, 1359117, 1426288
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
N460219103107followed by a unit qualifier and the quantityPackage 60219-1031-07. 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 tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets 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) The efficacy in females of reproductive potential with a body mass index of mo…
Excerpt only. Read the full label for complete information.
About NDC 60219-1031
- What is NDC 60219-1031?
- 60219-1031 is the product NDC for Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate 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?
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. 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 | — | KitOral | Amneal Pharmaceuticals LLC | 69238-1686 | 69238-1686-03 |
Other NDCs under ANDA 207514
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Melodetta 24 Fenorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Amneal Pharmaceuticals NY LLC | 69238-1031 |