Prescription drug · ANDA
Norethindrone Acetate and Ethinyl Estradiol NDC 68462-657
Norethindrone acetate 1 mg/1; Ethinyl estradiol 5 ug/1 · Tablet · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-657-29 | 6846206572968462065729 | 3 POUCH in 1 CARTON (68462-657-29) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACKMarketed from Apr 2, 2015 | |
| 68462-657-90 | 6846206579068462065790 | 90 TABLET in 1 BOTTLE (68462-657-90)Marketed from Apr 2, 2015 |
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
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol
- Active ingredients
- Norethindrone acetate — 1 mg/1Ethinyl estradiol — 5 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203038
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 68462-657_bc4774d0-9902-4678-af65-69d6a70d9983SPL ID bc4774d0-9902-4678-af65-69d6a70d9983SPL set ID cf549b5a-2707-4020-9f94-dab1260e1664RxCUI 1090992, 1251323, 1251334, 1251336UNII 9S44LIC7OJ, 423D2T571UUPC 0368462657294, 0368462656297
- 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
N468462065729followed by a unit qualifier and the quantityPackage 68462-0657-29. 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 tablets are a combination of an estrogen and progestin indicated in a woman with a uterus for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Prevention of Postmenopausal Osteoporosis ( 1.2 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
Excerpt only. Read the full label for complete information.
About NDC 68462-657
- What is NDC 68462-657?
- 68462-657 is the product NDC for Norethindrone Acetate and Ethinyl Estradiol, Norethindrone acetate 1 mg/1; Ethinyl estradiol 5 ug/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, 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?
- Norethindrone acetate, Ethinyl estradiol.
- 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?
- 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 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 | Ethinyl estradiol .02 mg/1; Norethindrone acetate 1 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-7280 | 00378-7280-53 |
Other NDCs under ANDA 203038
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 |
|---|---|---|---|---|
| Norethindrone Acetate and Ethinyl Estradiol | Norethindrone acetate .5 mg/1; Ethinyl estradiol 2.5 ug/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-656 |