What is NDC 68462-565?

68462-565 is the product NDC for Norgestimate and Ethinyl Estradiol kit, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 68462-565

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-565Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0565Add 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
68462-565-29	68462056529	3 BLISTER PACK in 1 CARTON (68462-565-29) / 1 KIT in 1 BLISTER PACK (68462-565-84)Marketed from Jun 17, 2011

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: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200494
Marketing start: Jun 17, 2011
Listing expires: Dec 31, 2027
Identifiers: Product ID 68462-565_fbb3fa97-10f6-482a-8d60-e67563ec2bfbSPL ID fbb3fa97-10f6-482a-8d60-e67563ec2bfbSPL set ID 8b247e46-203e-4f5b-b5a7-cbd57341c735RxCUI 240128, 406396, 687424, 748797, 749784, 749860UPC 0368462565292, 0368462309292

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

N468462056529 followed by a unit qualifier and the quantity

Package 68462-0565-29. 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 Feb 6, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Norgestimate and ethinyl estradiol tablets are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential 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 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 contr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-565

What is NDC 68462-565?: 68462-565 is the product NDC for Norgestimate and Ethinyl Estradiol kit, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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	42291-553	42291-0553-84
Norgestimate and Ethinyl Estradiol	—	Kit	AvKARE	42291-565	42291-0565-84
norgestimate and ethinyl estradiol	—	Kit	AvKARE	42291-590	42291-0590-84
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

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
Product	Strength	Form · route	Labeler	Product NDC
Norgestimate and Ethinyl Estradiol	—	Kit	A-S Medication Solutions	50090-2603
Norgestimate and Ethinyl Estradiol	—	Kit	Proficient Rx LP	71205-191