NDC codes

FDA NDC Directory
Product NDC (as listed)50090-2603Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-2603Add 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 NDC11-digit (billing)PackageCopy
50090-2603-0500902603001 KIT in 1 KIT (50090-2603-0)Marketed from Nov 8, 2016

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)
Norgestimate and Ethinyl Estradiol
Generic name (nonproprietary)
norgestimate and ethinyl estradiol
Dosage form
Kit
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200494
Marketing start
Listing expires
Identifiers
Product ID 50090-2603_d6d5083b-19d9-45b5-9373-f7c2489faaf0SPL ID d6d5083b-19d9-45b5-9373-f7c2489faaf0SPL set ID 6ae97238-28cf-4bc9-a4ba-1e2bf4e3c600RxCUI 240128, 406396, 687424, 748797, 749784

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

N450090260300 followed by a unit qualifier and the quantity

Package 50090-2603-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Norgestimate and ethinyl estradiol tablets are estrogen/progestin COCs, indicated for use by women to prevent pregnancy. ( 1.1 ) Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg are also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and ethinyl estradiol tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Norgestimate and Ethinyl Estradiol Tablets…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-2603

What is NDC 50090-2603?
50090-2603 is the product NDC for Norgestimate and Ethinyl Estradiol kit, listed with the FDA by A-S Medication Solutions. 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?
A-S Medication Solutions, NDC labeler code 50090. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Norgestimate and ethinyl estradiol—KitNaari Pte Limited79929-00879929-0008-07
Norgestimate and ethinyl estradiol—KitNaari Pte Limited79929-00979929-0009-07
Norgestimate and Ethinyl Estradiol—KitAvKARE42291-55342291-0553-84
Norgestimate and Ethinyl Estradiol—KitAvKARE42291-56542291-0565-84
norgestimate and ethinyl estradiol—KitAvKARE42291-59042291-0590-84
norgestimate and ethinyl estradiol—KitPD-Rx Pharmaceuticals, Inc.72789-43572789-0435-79
Norgestimate and Ethinyl Estradiol—KitLupin Pharmaceuticals, Inc.68180-84068180-0840-73
Norgestimate and ethinyl estradiol—KitLupin Pharmaceuticals, Inc.68180-83868180-0838-73
Norgestimate and Ethinyl Estradiol—KitA-S Medication Solutions50090-225950090-2259-00
Norgestimate and Ethinyl Estradiol—KitGlenmark Pharmaceuticals Inc., USA68462-30968462-0309-29

All 14 Norgestimate and Ethinyl Estradiol NDCs

Other NDCs under ANDA 200494

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

FDA NDC Directory listings under ANDA 200494
ProductStrengthForm · routeLabelerProduct NDC
Norgestimate and Ethinyl Estradiol—KitGlenmark Pharmaceuticals Inc., USA68462-565
Norgestimate and Ethinyl Estradiol—KitProficient Rx LP71205-191

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