Norgestimate and Ethinyl Estradiol NDC 42291-553

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-553Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0553Add 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
42291-553-84	42291055384	3 CARTON in 1 CARTON (42291-553-84) / 1 BLISTER PACK in 1 CARTON (42291-553-28) / 1 KIT in 1 BLISTER PACKMarketed from Apr 20, 2020

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): Norgestimate and Ethinyl Estradiol
Generic name (nonproprietary): norgestimate and ethinyl estradiol
Dosage form: Kit
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090794
Marketing start: Apr 20, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 42291-553_0e9917ff-3789-1cfe-e063-6294a90a7a6fSPL ID 0e9917ff-3789-1cfe-e063-6294a90a7a6fSPL set ID a3c0c983-7ec7-244a-e053-2995a90adbe4RxCUI 240128, 748797, 749860

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

N442291055384 followed by a unit qualifier and the quantity

Package 42291-0553-84. 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 Jan 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Norgestimate and Ethinyl Estradiol Tablets are an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive Norgestimate and Ethinyl Estradiol Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14) ] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090794

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

FDA NDC Directory listings under ANDA 090794
Product	Strength	Form · route	Labeler	Product NDC
Estaryllanorgestimate and ethinyl estradiol	—	Kit	Proficient Rx LP	82804-158
Estaryllanorgestimate and ethinyl estradiol	—	Kit	Xiromed, LLC.	70700-119
Estaryllanorgestimate and ethinyl estradiol	—	Kit	Bryant Ranch Prepack	63629-2349