Prescription drug · ANDA
Norethindrone Acetate and Ethinyl Estradiol NDC 70700-101
norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets · Kit · Oral · Xiromed, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-101-85 | 7070001018570700010185 | 3 BLISTER PACK in 1 CARTON (70700-101-85) / 1 KIT in 1 BLISTER PACKMarketed from Aug 24, 2018 |
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 tablets and ferrous fumarate tablets
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Xiromed, LLCNDC labeler code 70700
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209609
- Marketing start
- Listing expires
- Identifiers
- Product ID 70700-101_0b7a2fac-2281-4c64-29aa-5e0d05d49236SPL ID 0b7a2fac-2281-4c64-29aa-5e0d05d49236SPL set ID b4bc4302-9484-465a-090d-47e1e0360b73RxCUI 259176, 1426288, 1426600
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
N470700010185followed by a unit qualifier and the quantityPackage 70700-0101-85. 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 and ferrous fumarate tablets is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies ( 14 )] The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets is an estrogen/progestin COC indicated for use by women to prevent pregnancy ( 1 ) The efficacy in women with a body mass index of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 )
Excerpt only. Read the full label for complete information.
About NDC 70700-101
- What is NDC 70700-101?
- 70700-101 is the product NDC for Norethindrone Acetate and Ethinyl Estradiol kit, listed with the FDA by Xiromed, LLC. 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 (Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets).
- Who is the labeler?
- Xiromed, LLC, NDC labeler code 70700. 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 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 |