NDC codes

FDA NDC Directory
Product NDC (as listed)68462-303Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0303Add 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
68462-303-2968462030329684620303293 BLISTER PACK in 1 CARTON (68462-303-29) / 28 TABLET in 1 BLISTER PACK (68462-303-84)Marketed from Apr 23, 2010 · Sample package

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)
Heather
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 090454
Marketing start
Listing expires
Other FDA classes
Progesterone Congeners (Chemical structure)
Identifiers
Product ID 68462-303_9240d076-c4e6-4897-af0b-a2c403a6f06dSPL ID 9240d076-c4e6-4897-af0b-a2c403a6f06dSPL set ID 35b5ddb5-1729-4588-b2a2-ead56d78b6f9RxCUI 198042, 748961, 977836UNII T18F433X4SUPC 0368462303290
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

N468462030329 followed by a unit qualifier and the quantity

Package 68462-0303-29. 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 .

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 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2. 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 Contraceptive Pills: Treatment initiate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-303

What is NDC 68462-303?
68462-303 is the product NDC for Heather (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?
Heather (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 Heather?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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