Prescription drug · ANDA
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate NDC 68462-849
Kit · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-849-29 | 6846208492968462084929 | 3 CARTON in 1 BOX (68462-849-29) / 1 BLISTER PACK in 1 CARTON (68462-849-84) / 1 KIT in 1 BLISTER PACK * 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-821-40) * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-822-40)Marketed from Jul 27, 2022 |
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)
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213418
- Marketing start
- Listing expires
- Identifiers
- Product ID 68462-849_920756d5-a617-404c-968d-ccf58740fa1eSPL ID 920756d5-a617-404c-968d-ccf58740fa1eSPL set ID 3e608414-5e64-4c69-a9e0-365904cf7df8RxCUI 1421459, 1421460, 1421461UPC 0368462849842
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
N468462084929followed by a unit qualifier and the quantityPackage 68462-0849-29. 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. • 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 ) • The efficacy of norethindrone acetate and ethinyl estradiol capsu…
Excerpt only. Read the full label for complete information.
About NDC 68462-849
- What is NDC 68462-849?
- 68462-849 is the product NDC for Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate kit, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 | — | KitOral | Amneal Pharmaceuticals LLC | 69238-1686 | 69238-1686-03 |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | — | Kit | Amneal Pharmaceuticals NY LLC | 60219-1031 | 60219-1031-07 |