NDC codes

FDA NDC Directory
Product NDC (as listed)0430-0420Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00430-0420Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0430-0420-14004300420145 BLISTER PACK in 1 CARTON (0430-0420-14) / 1 KIT in 1 BLISTER PACKMarketed from Dec 1, 2010
0430-0420-60004300420608 CARTON in 1 TRAY (0430-0420-60) / 30 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACKMarketed from Dec 1, 2010
0430-0420-95004300420956 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
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

N400430042014 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022501

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 022501
ProductStrengthForm · routeLabelerProduct NDC
Lo Loestrin Fenorethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate—KitA-S Medication Solutions50090-1456

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