NDC 68462-376

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-376Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0376Add 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 NDC	11-digit (billing)	Package	Copy
68462-376-29	68462037629	3 BLISTER PACK in 1 CARTON (68462-376-29) / 1 KIT in 1 BLISTER PACKMarketed from Dec 26, 2017

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 and ferrous fumarate
Generic name (nonproprietary): norethindrone acetate and ethinyl estradiol and ferrous fumarate
Dosage form: Kit
Labeler: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210369
Marketing start: Dec 26, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 68462-376_c38d6eb8-e70a-415a-ae54-daf53998112aSPL ID c38d6eb8-e70a-415a-ae54-daf53998112aSPL set ID 570670c0-b88f-4e78-a978-498aff52b410RxCUI 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 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

N468462037629 followed by a unit qualifier and the quantity

Package 68462-0376-29. 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 Dec 26, 2017. This label includes a boxed warning.

Indications (excerpt from the label)

Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are 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 are 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210369

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

FDA NDC Directory listings under ANDA 210369
Product	Strength	Form · route	Labeler	Product NDC
Charlotte 24Fenorethindrone acetate and ethinyl estradiol and ferrous fumarate	—	Kit	Glenmark Pharmaceuticals Inc., USA	68462-852

norethindrone acetate and ethinyl estradiol and ferrous fumarate NDC 68462-376