NDC 60219-1031

NDC codes

FDA NDC Directory

Product NDC (as listed)60219-1031Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60219-1031Add 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
60219-1031-7	60219103107	3 BLISTER PACK in 1 CARTON (60219-1031-7) / 1 KIT in 1 BLISTER PACK (60219-1031-6)Marketed from Sep 21, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Amneal Pharmaceuticals NY LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207514
Marketing start: Sep 21, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 60219-1031_ae13db8f-27e2-420a-b909-99d0347e6286SPL ID ae13db8f-27e2-420a-b909-99d0347e6286SPL set ID d4fa03d8-0ae0-497f-ba4e-76f03fd7a3abRxCUI 259176, 1358762, 1359117, 1426288

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

N460219103107 followed by a unit qualifier and the quantity

Package 60219-1031-07. 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 Jul 18, 2023. 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 a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy (1) The efficacy in females of reproductive potential with a body mass index of mo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207514

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

FDA NDC Directory listings under ANDA 207514
Product	Strength	Form · route	Labeler	Product NDC
Melodetta 24 Fenorethindrone acetate and ethinyl estradiol and ferrous fumarate	—	Kit	Amneal Pharmaceuticals NY LLC	69238-1031

Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate NDC 60219-1031