Prescription drug · ANDA
Norethindrone And Ethinyl Estradiol And Ferrous Fumarate NDC 0378-7297
Kit · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-7297-53 | 0037872975300378729753 | 3 POUCH in 1 CARTON (0378-7297-53) / 1 BLISTER PACK in 1 POUCH (0378-7297-85) / 1 KIT in 1 BLISTER PACKMarketed from Oct 28, 2016 |
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 And Ethinyl Estradiol And Ferrous Fumarate
- Generic name (nonproprietary)
- norethindrone 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 202086
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-7297_4805e8cc-2bd9-6f76-cb1f-2d818160ac24SPL ID 4805e8cc-2bd9-6f76-cb1f-2d818160ac24SPL set ID aabda044-9f17-4f1f-bb8d-2a78c9066fdcRxCUI 433718, 1095223, 1095224
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
N400378729753followed by a unit qualifier and the quantityPackage 00378-7297-53. 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)
Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are indicated for use by females of reproductive potential to prevent pregnancy. • Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are 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 0378-7297
- What is NDC 0378-7297?
- 0378-7297 is the product NDC for Norethindrone 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 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 And Ethinyl Estradiol And Ferrous Fumarate?
- 1 other product NDC are listed under this name. See all Norethindrone 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 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 and ethinyl estradiol and ferrous fumaratenorethindrone and ethinyl estradiol and ferrous fumarate tablet | — | Kit | Naari Pte Limited | 79929-005 | 79929-0005-07 |
Other NDCs under ANDA 202086
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 |
|---|---|---|---|---|
| Xelria Fenorethindrone and ethinyl estradiol and ferrous fumarate | — | Kit | Xiromed LLC | 70700-308 |