NDC 0378-7303

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7303Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7303Add 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
0378-7303-53	00378730353	3 POUCH in 1 CARTON (0378-7303-53) / 1 BLISTER PACK in 1 POUCH (0378-7303-85) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (0378-7191-71) * 9 TABLET in 1 BLISTER PACK (0378-7192-59) * 7 TABLET in 1 BLISTER PACK (0378-7193-71) * 5 TABLET in 1 BLISTER PACK (0378-7190-98)Marketed from Jul 27, 2022

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 Acetate And Ethinyl Estradiol And Ferrous Fumarate
Generic name (nonproprietary): norethindrone acetate 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 205069
Marketing start: Jul 27, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 0378-7303_931f0bbe-68fa-5010-6d73-7f97e3d9eddfSPL ID 931f0bbe-68fa-5010-6d73-7f97e3d9eddfSPL set ID 054917fa-573b-4b16-a719-ece6c0909656RxCUI 259176, 1358762, 1359130, 1359131, 1359132

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

N400378730353 followed by a unit qualifier and the quantity

Package 00378-7303-53. 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 Nov 29, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be used for the treatment …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205069

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

FDA NDC Directory listings under ANDA 205069
Product	Strength	Form · route	Labeler	Product NDC
Xarah Fenorethindrone acetate and ethinyl estradiol and ferrous fumarate tablets	—	Kit	Xiromed LLC	70700-310

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate NDC 0378-7303