Prescription drug · NDA
Lo Loestrin Fe NDC 0430-0420
Kit · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0430-0420-14 | 00430042014 | 5 BLISTER PACK in 1 CARTON (0430-0420-14) / 1 KIT in 1 BLISTER PACKMarketed from Dec 1, 2010 | |
| 0430-0420-60 | 00430042060 | 8 CARTON in 1 TRAY (0430-0420-60) / 30 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACKMarketed from Dec 1, 2010 | |
| 0430-0420-95 | 00430042095 | 6 CARTON in 1 TRAY (0430-0420-95) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACKMarketed from Dec 1, 2010 · Sample package |
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)
- Lo Loestrin Fe
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Allergan, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022501
- Marketing start
- Listing expires
- Identifiers
- Product ID 0430-0420_10c71417-7163-43ca-bcce-8a12590ebccfSPL ID 10c71417-7163-43ca-bcce-8a12590ebccfSPL set ID c33072cf-625d-4b4a-981e-ec049c5d78aaRxCUI 248310, 259176, 1037183, 1037184, 1037185
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
N400430042014followed by a unit qualifier and the quantityPackage 00430-0420-14. 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)
Lo Loestrin ® Fe is indicated for use by women to prevent pregnancy [ see Clinical Studies (14) ] . The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Lo Loestrin Fe 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 Lo Loestrin Fe in women with a body mass index of > 35 kg/m 2 has not been evaluated ( 1 , 8.8 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022501
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 |
|---|---|---|---|---|
| Lo Loestrin Fenorethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate | — | Kit | A-S Medication Solutions | 50090-1456 |