Prescription drug · ANDA
Mibelas 24 Fe NDC 68180-911
norethindrone acetate, ethinyl estradiol and ferrous fumarate · Kit · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-911-73 | 6818009117368180091173 | 3 POUCH in 1 CARTON (68180-911-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Mar 31, 2020 |
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)
- Mibelas 24 Fe
- Generic name (nonproprietary)
- norethindrone acetate, ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206287
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-911_4da34ed3-8449-46a5-b662-b30042df51ebSPL ID 4da34ed3-8449-46a5-b662-b30042df51ebSPL set ID 7281519c-069c-4ce3-a076-49848ad4ee7bRxCUI 259176, 1426288, 1426600, 1873704UPC 0368180911715
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
N468180091173followed by a unit qualifier and the quantityPackage 68180-0911-73. 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)
Mibelas 24 Fe 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 ) Mibelas™ 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see CLINICAL STUDIES ( 14 )]. The efficacy of Mibelas 24 Fe in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated.
Excerpt only. Read the full label for complete information.
About NDC 68180-911
- What is NDC 68180-911?
- 68180-911 is the product NDC for Mibelas 24 Fe kit, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mibelas 24 Fe (Norethindrone acetate, Ethinyl estradiol and ferrous fumarate).
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mibelas 24 Fe?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.