Prescription drug · ANDA
Norethindrone Acetate And Ethinyl Estradiol NDC 0378-7274
Ethinyl estradiol .03 mg/1; Norethindrone acetate 1.5 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-7274-53 | 0037872745300378727453 | 3 POUCH in 1 CARTON (0378-7274-53) / 1 BLISTER PACK in 1 POUCH (0378-7274-85) / 21 TABLET in 1 BLISTER PACKMarketed from Sep 25, 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
- Active ingredients
- Ethinyl estradiol — .03 mg/1Norethindrone acetate — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202770
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0378-7274_8a7faa9f-224f-fb2e-fde2-986d2142dc2fSPL ID 8a7faa9f-224f-fb2e-fde2-986d2142dc2fSPL set ID 3108a9bc-3378-459d-8f6b-bd5eff2ad657RxCUI 1359022, 1359028UNII 423D2T571U, 9S44LIC7OJ
- Pharmacologic class
- Estrogen; Progestin
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400378727453followed by a unit qualifier and the quantityPackage 00378-7274-53. 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 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 Adapted from RA Hatcher et al, …
Excerpt only. Read the full label for complete information.
About NDC 0378-7274
- What is NDC 0378-7274?
- 0378-7274 is the product NDC for Norethindrone Acetate And Ethinyl Estradiol, Ethinyl estradiol .03 mg/1; Norethindrone acetate 1.5 mg/1 tablet, 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.
- What is the active ingredient?
- Ethinyl estradiol, Norethindrone acetate.
- 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 | — | Kit | Mylan Pharmaceuticals Inc. | 0378-7288 | 00378-7288-53 |
| 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 202770
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 |
|---|---|---|---|---|
| Luizza 1.5/30norethindrone acetate and ethinyl estradiol | Ethinyl estradiol 30 ug/1; Norethindrone acetate 1.5 mg/1 | TabletOral | Xiromed LLC | 70700-314 |