NDC 0378-7297

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7297Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7297Add 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
0378-7297-53	00378729753	3 POUCH in 1 CARTON (0378-7297-53) / 1 BLISTER PACK in 1 POUCH (0378-7297-85) / 1 KIT in 1 BLISTER PACKMarketed from Oct 28, 2016

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): Norethindrone And Ethinyl Estradiol And Ferrous Fumarate
Generic name (nonproprietary): norethindrone and ethinyl estradiol and ferrous fumarate
Dosage form: Kit
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202086
Marketing start: Oct 28, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 0378-7297_4805e8cc-2bd9-6f76-cb1f-2d818160ac24SPL ID 4805e8cc-2bd9-6f76-cb1f-2d818160ac24SPL set ID aabda044-9f17-4f1f-bb8d-2a78c9066fdcRxCUI 433718, 1095223, 1095224

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

N400378729753 followed by a unit qualifier and the quantity

Package 00378-7297-53. 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 1, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are indicated for use by females of reproductive potential to prevent pregnancy. • Norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate tablets (chewable) are a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202086

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

FDA NDC Directory listings under ANDA 202086
Product	Strength	Form · route	Labeler	Product NDC
Xelria Fenorethindrone and ethinyl estradiol and ferrous fumarate	—	Kit	Xiromed LLC	70700-308

Norethindrone And Ethinyl Estradiol And Ferrous Fumarate NDC 0378-7297