What is NDC 68462-305?

68462-305 is the product NDC for Norethindrone, Norethindrone .35 mg/1 tablet, 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 Norethindrone?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Norethindrone NDC 68462-305 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-305Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0305Add 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
68462-305-29	6846203052968462030529	3 POUCH in 1 CARTON (68462-305-29) / 28 TABLET in 1 POUCH (68462-305-84)Marketed from Nov 3, 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
Generic name (nonproprietary): norethindrone
Active ingredients: Norethindrone — .35 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 091209
Marketing start: Nov 3, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 68462-305_5a1f7007-bfeb-4899-a1a3-b3c005cbcabbSPL ID 5a1f7007-bfeb-4899-a1a3-b3c005cbcabbSPL set ID 0d2f8fea-3675-40d2-afd9-9fcb148dbd4bRxCUI 198042, 748961UNII T18F433X4SUPC 0368462305843
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

N468462030529 followed by a unit qualifier and the quantity

Package 68462-0305-29. 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 Jan 31, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE 1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. Emergency Contraception: Emergency contraceptive pills or ins…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-305

What is NDC 68462-305?: 68462-305 is the product NDC for Norethindrone, Norethindrone .35 mg/1 tablet, 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?: Norethindrone.
What is the active ingredient?: Norethindrone.
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?: 5 other product NDCs are listed under this name. See all Norethindrone 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Norethindrone	Norethindrone .35 mg/1	TabletOral	A-S Medication Solutions	50090-6161	50090-6161-00
Norethindrone	Norethindrone .35 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-876	68180-0876-73
Norethindrone	Norethindrone .35 mg/1	TabletOral	Proficient Rx LP	82804-175	82804-0175-28
Norethindrone	Norethindrone .35 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-7292	00378-7292-53
Norethindrone	Norethindrone .35 mg/1	TabletOral	Proficient Rx LP	63187-748	63187-0748-28

Other NDCs under ANDA 091209

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

FDA NDC Directory listings under ANDA 091209
Product	Strength	Form · route	Labeler	Product NDC
Norethindrone	Norethindrone .35 mg/1	TabletOral	Proficient Rx LP	63187-748