What is NDC 68462-304?

68462-304 is the product NDC for Norethindrone Acetate, Norethindrone acetate 5 mg/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, 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 Norethindrone Acetate?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Norethindrone Acetate NDC 68462-304

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-304Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0304Add 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
68462-304-05	6846203040568462030405	500 TABLET in 1 BOTTLE (68462-304-05)Marketed from Jul 21, 2010
68462-304-50	6846203045068462030450	50 TABLET in 1 BOTTLE (68462-304-50)Marketed from Jul 21, 2010

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): Norethindrone Acetate
Generic name (nonproprietary): norethindrone acetate
Active ingredients: Norethindrone acetate — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091090
Marketing start: Jul 21, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 68462-304_61f08f82-c9ec-45cf-ab8b-18afabde75e2SPL ID 61f08f82-c9ec-45cf-ab8b-18afabde75e2SPL set ID d0a94321-eb60-4aa6-a429-f0156f9f8e01RxCUI 1000405UNII 9S44LIC7OJUPC 0368462304501
Pharmacologic class: Progestin

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468462030405 followed by a unit qualifier and the quantity

Package 68462-0304-05. 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 29, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Norethindrone acetate is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Norethindrone acetate is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-304

What is NDC 68462-304?: 68462-304 is the product NDC for Norethindrone Acetate, Norethindrone acetate 5 mg/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Norethindrone Acetate.
What is the active ingredient?: Norethindrone acetate.
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 Norethindrone Acetate?: 6 other product NDCs are listed under this name. See all Norethindrone Acetate 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 Norethindrone Acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Norethindrone Acetate	Norethindrone acetate 5 mg/1	TabletOral	American Health Packaging	60687-921	60687-0921-21
Norethindrone acetate	Norethindrone acetate 5 mg/1	TabletOral	Ingenus Pharmaceuticals, LLC	50742-267	50742-0267-50
Norethindrone Acetatenorethindrone	Norethindrone acetate 5 mg/1	TabletOral	AvKARE	42291-650	42291-0650-90
Norethindrone Acetatenorethindrone	Norethindrone acetate 5 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-475	65162-0475-0365162-0475-0565162-0475-09+1 more
Norethindrone Acetate	Norethindrone acetate 5 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0211	00555-0211-10
Norethindrone Acetate	Norethindrone acetate 5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-599	51407-0599-50

Other NDCs under ANDA 091090

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

FDA NDC Directory listings under ANDA 091090
Product	Strength	Form · route	Labeler	Product NDC
Norethindrone Acetate	Norethindrone acetate 5 mg/1	TabletOral	American Health Packaging	60687-921