Minivelle (estradiol) NDC 68968-6610

NDC codes

FDA NDC Directory

Product NDC (as listed)68968-6610Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68968-6610Add 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
68968-6610-8	68968661008	8 POUCH in 1 PACKET (68968-6610-8) / 1 d in 1 POUCHMarketed from Dec 20, 2012

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): Minivelle
Generic name (nonproprietary): estradiol
Active ingredients: Estradiol — .1 mg/d
Dosage form: Film, Extended release
Route: Transdermal
Labeler: Noven Therapeutics, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203752
Marketing start: Dec 20, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 68968-6610_0d1f7ac0-2185-451c-bd3f-0a5a67ef8d54SPL ID 0d1f7ac0-2185-451c-bd3f-0a5a67ef8d54SPL set ID 6c5c47ab-28ee-11e1-bfc2-0800200c9a66RxCUI 241946, 242891, 242892, 248478, 1149632, 1356979, 1356997, 1357007, 1357009, 1551622UNII 4TI98Z838EUPC 0368968665083
Pharmacologic class: Estrogen

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

N468968661008 followed by a unit qualifier and the quantity

Package 68968-6610-08. 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 Jul 31, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

MINIVELLE is indicated for: MINIVELLE® is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) Prevention of postmenopausal osteoporosis ( 1.2 ) Limitations of Use When prescribing solely for the treatment of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 203752

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

FDA NDC Directory listings under NDA 203752
Product	Strength	Form · route	Labeler	Product NDC
Estradiol	Estradiol .0375 mg/d	Film, Extended releaseTransdermal	A-S Medication Solutions	50090-7610
Estradiol	Estradiol .05 mg/d	Film, Extended releaseTransdermal	Noven Therapeutics, LLC	68968-3450
Estradiol	Estradiol .1 mg/d	Film, Extended releaseTransdermal	Noven Therapeutics, LLC	68968-3410
Estradiol	Estradiol .025 mg/d	Film, Extended releaseTransdermal	Noven Therapeutics, LLC	68968-3425
Estradiol	Estradiol .0375 mg/d	Film, Extended releaseTransdermal	Noven Therapeutics, LLC	68968-3437
Estradiol	Estradiol .075 mg/d	Film, Extended releaseTransdermal	Noven Therapeutics, LLC	68968-3475
Minivelleestradiol	Estradiol .025 mg/d	Film, Extended releaseTransdermal	Noven Therapeutics, LLC	68968-6625
Minivelleestradiol	Estradiol .0375 mg/d	Film, Extended releaseTransdermal	Noven Therapeutics, LLC	68968-6637
Minivelleestradiol	Estradiol .05 mg/d	Film, Extended releaseTransdermal	Noven Therapeutics, LLC	68968-6650
Minivelleestradiol	Estradiol .075 mg/d	Film, Extended releaseTransdermal	Noven Therapeutics, LLC	68968-6675