Prescription drug · NDA
CombiPatch (estradiol/norethindrone acetate transdermal system) NDC 68968-0525
estradiol/norethindrone acetate transdermal system · Estradiol .05 mg/d; Norethindrone acetate .25 mg/d · Patch, Extended release · Transdermal · Noven Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68968-0525-8 | 6896805250868968052508 | 8 POUCH in 1 CARTON (68968-0525-8) / 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 — .25 mg/d
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Noven Therapeutics, LLCNDC labeler code 68968
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020870
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 68968-0525_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
N468968052508followed by a unit qualifier and the quantityPackage 68968-0525-08. 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 . 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.
About NDC 68968-0525
- What is NDC 68968-0525?
- 68968-0525 is the product NDC for CombiPatch (estradiol/norethindrone acetate transdermal system), Estradiol .05 mg/d; Norethindrone acetate .25 mg/d patch, extended release, listed with the FDA by Noven Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CombiPatch (estradiol/norethindrone acetate transdermal system) (Estradiol/norethindrone acetate transdermal system).
- What is the active ingredient?
- Estradiol, Norethindrone acetate.
- Who is the labeler?
- Noven Therapeutics, LLC, NDC labeler code 68968. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CombiPatch (estradiol/norethindrone acetate transdermal system)?
- 1 other product NDC are listed under this name. See all CombiPatch (estradiol/norethindrone acetate transdermal system) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CombiPatch (estradiol/norethindrone acetate transdermal system) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal system | Estradiol .05 mg/d; Norethindrone acetate .14 mg/d | Patch, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0514 | 68968-0514-08 |
Other NDCs under NDA 020870
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal system | Estradiol .05 mg/d; Norethindrone acetate .14 mg/d | Patch, Extended releaseTransdermal | Noven Therapeutics, LLC | 68968-0514 |