What is NDC 42291-553?

42291-553 is the product NDC for Norgestimate and Ethinyl Estradiol kit, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Norgestimate and Ethinyl Estradiol?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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: AvKARENDC labeler code 42291
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)

About NDC 42291-553

What is NDC 42291-553?: 42291-553 is the product NDC for Norgestimate and Ethinyl Estradiol kit, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Norgestimate and Ethinyl Estradiol.
Who is the labeler?: AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Norgestimate and Ethinyl Estradiol?: 13 other product NDCs are listed under this name. See all Norgestimate and Ethinyl Estradiol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Norgestimate and Ethinyl Estradiol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Norgestimate and ethinyl estradiol	—	Kit	Naari Pte Limited	79929-008	79929-0008-07
Norgestimate and ethinyl estradiol	—	Kit	Naari Pte Limited	79929-009	79929-0009-07
norgestimate and ethinyl estradiol	—	Kit	AvKARE	42291-590	42291-0590-84
Norgestimate and Ethinyl Estradiol	—	Kit	AvKARE	42291-565	42291-0565-84
norgestimate and ethinyl estradiol	—	Kit	PD-Rx Pharmaceuticals, Inc.	72789-435	72789-0435-79
Norgestimate and Ethinyl Estradiol	—	Kit	Lupin Pharmaceuticals, Inc.	68180-840	68180-0840-73
Norgestimate and ethinyl estradiol	—	Kit	Lupin Pharmaceuticals, Inc.	68180-838	68180-0838-73
Norgestimate and Ethinyl Estradiol	—	Kit	A-S Medication Solutions	50090-2259	50090-2259-00
Norgestimate and Ethinyl Estradiol	—	Kit	Glenmark Pharmaceuticals Inc., USA	68462-309	68462-0309-29
Norgestimate and Ethinyl Estradiol	—	Kit	A-S Medication Solutions	50090-2603	50090-2603-00

All 14 Norgestimate and Ethinyl Estradiol NDCs

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