Prescription drug · ANDA
Norethindrone Acetate And Ethinyl Estradiol NDC 0378-7288
Kit · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-7288-53 | 0037872885300378728853 | 3 POUCH in 1 CARTON (0378-7288-53) / 1 BLISTER PACK in 1 POUCH (0378-7288-85) / 1 KIT in 1 BLISTER PACKMarketed from Dec 16, 2019 |
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
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol
- 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 202741
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-7288_ef1c54ca-92fb-677c-b2fe-46a2f872046aSPL ID ef1c54ca-92fb-677c-b2fe-46a2f872046aSPL set ID 4423eebd-6397-4330-85a8-baa2e736767aRxCUI 259176, 1359022, 1359023
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
N400378728853followed by a unit qualifier and the quantityPackage 00378-7288-53. 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 oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD A…
Excerpt only. Read the full label for complete information.
About NDC 0378-7288
- What is NDC 0378-7288?
- 0378-7288 is the product NDC for Norethindrone Acetate And Ethinyl Estradiol 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.
- 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?
- 7 other product NDCs are listed under this name. See all Norethindrone Acetate And Ethinyl Estradiol 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 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 | Ethinyl estradiol .03 mg/1; Norethindrone acetate 1.5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-7274 | 00378-7274-53 |
| Norethindrone Acetate and Ethinyl Estradiolnorethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets | — | KitOral | Xiromed, LLC | 70700-101 | 70700-0101-85 |
| Norethindrone Acetate and Ethinyl Estradiol | Norethindrone acetate 1 mg/1; Ethinyl estradiol .02 mg/1 | TabletOral | A-S Medication Solutions | 50090-6782 | 50090-6782-00 |
| Norethindrone Acetate and Ethinyl Estradiol | Norethindrone acetate 1 mg/1; Ethinyl estradiol .02 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-132 | 68462-0132-81 |
| Norethindrone Acetate and Ethinyl Estradiol | Norethindrone acetate .5 mg/1; Ethinyl estradiol 2.5 ug/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-656 | 68462-0656-2968462-0656-90 |
| Norethindrone Acetate and Ethinyl Estradiol | Norethindrone acetate 1 mg/1; Ethinyl estradiol 5 ug/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-657 | 68462-0657-2968462-0657-90 |
| Norethindrone Acetate And Ethinyl Estradiol | Ethinyl estradiol .02 mg/1; Norethindrone acetate 1 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-7280 | 00378-7280-53 |
Other NDCs under ANDA 202741
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 |
|---|---|---|---|---|
| Feirza 1.5/30 Tmnorethindrone acetate and ethinyl estradiol tablets usp, 1.5 mg/30 mcg and ferrous fumarate tablets, 75 mg | — | Kit | Xiromed LLC | 70700-309 |