NDC 68968-0514

NDC codes

FDA NDC Directory

Product NDC (as listed)68968-0514Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68968-0514Add 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
68968-0514-8	68968051408	8 POUCH in 1 CARTON (68968-0514-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCHMarketed from Aug 7, 1998

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): CombiPatch (estradiol/norethindrone acetate transdermal system)
Generic name (nonproprietary): estradiol/norethindrone acetate transdermal system
Active ingredients: Estradiol — .05 mg/dNorethindrone acetate — .14 mg/d
Dosage form: Patch, Extended release
Route: Transdermal
Labeler: Noven Therapeutics, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020870
Marketing start: Aug 7, 1998
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 68968-0514_a8dddb67-4c56-4d1d-a4ce-83dc426d33f6SPL ID a8dddb67-4c56-4d1d-a4ce-83dc426d33f6SPL set ID 83198ef1-11c4-11e4-9191-0800200c9a66RxCUI 1251493, 1251495, 1251499, 1251501UNII 9S44LIC7OJ, 4TI98Z838E
Pharmacologic class: Estrogen; 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468968051408 followed by a unit qualifier and the quantity

Package 68968-0514-08. 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 21, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE CombiPatch is indicated in a woman with a uterus for: Treatment of moderate to severe vasomotor symptoms due to menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020870

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

FDA NDC Directory listings under NDA 020870
Product	Strength	Form · route	Labeler	Product NDC
CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal system	Estradiol .05 mg/d; Norethindrone acetate .25 mg/d	Patch, Extended releaseTransdermal	Noven Therapeutics, LLC	68968-0525

CombiPatch (estradiol/norethindrone acetate transdermal system) NDC 68968-0514