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	68462030405	500 TABLET in 1 BOTTLE (68462-304-05)Marketed from Jul 21, 2010
68462-304-50	68462030450	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., USA
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)

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