Prescription drug · ANDA
Junel Fe 24 NDC 0093-5328
norethindrone acetate and ethinyl estradiol and ferrous fumarate · Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-5328-62 | 00093532862 | 3 POUCH in 1 CARTON (0093-5328-62) / 1 BLISTER PACK in 1 POUCH (0093-5328-28) / 1 KIT in 1 BLISTER PACKMarketed from Jun 8, 2015 |
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)
- Junel Fe 24Suffix: 24
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090938
- Marketing start
- Listing expires
- Identifiers
- Product ID 0093-5328_52a655e8-8040-4ecd-9d45-0122ea4ea6d2SPL ID 52a655e8-8040-4ecd-9d45-0122ea4ea6d2SPL set ID ffbf48de-0f61-49f9-9cd5-6eb8e08040dbRxCUI 259176, 1358762, 1359117, 1652084
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
N400093532862followed by a unit qualifier and the quantityPackage 00093-5328-62. 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)
Junel ® Fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is indicated for use by women to prevent pregnancy [see Clinical Studies ( 14 )] . The efficacy of Junel Fe 24 in women with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. Junel ® Fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. (1) The efficacy of Junel Fe 24 in women with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 )
Excerpt only. Read the full label for complete information.
- openFDA data updated
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