Prescription drug · ANDA
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate NDC 0378-7303
Kit · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-7303-53 | 0037873035300378730353 | 3 POUCH in 1 CARTON (0378-7303-53) / 1 BLISTER PACK in 1 POUCH (0378-7303-85) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (0378-7191-71) * 9 TABLET in 1 BLISTER PACK (0378-7192-59) * 7 TABLET in 1 BLISTER PACK (0378-7193-71) * 5 TABLET in 1 BLISTER PACK (0378-7190-98)Marketed from Jul 27, 2022 |
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)
- Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205069
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-7303_931f0bbe-68fa-5010-6d73-7f97e3d9eddfSPL ID 931f0bbe-68fa-5010-6d73-7f97e3d9eddfSPL set ID 054917fa-573b-4b16-a719-ece6c0909656RxCUI 259176, 1358762, 1359130, 1359131, 1359132
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
N400378730353followed by a unit qualifier and the quantityPackage 00378-7303-53. 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)
INDICATIONS AND USAGE Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be used for the treatment …
Excerpt only. Read the full label for complete information.
About NDC 0378-7303
- What is NDC 0378-7303?
- 0378-7303 is the product NDC for Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate kit, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 | 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 |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | — | Kit | Amneal Pharmaceuticals NY LLC | 60219-1031 | 60219-1031-07 |
Other NDCs under ANDA 205069
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 |
|---|---|---|---|---|
| Xarah Fenorethindrone acetate and ethinyl estradiol and ferrous fumarate tablets | — | Kit | Xiromed LLC | 70700-310 |