Prescription drug · NDA

Minivelle (estradiol) NDC 68968-6650

Estradiol .05 mg/d · Film, Extended release · Transdermal · Noven Therapeutics, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)68968-6650Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68968-6650Add 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
68968-6650-8689686650088 POUCH in 1 PACKET (68968-6650-8) / 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 — .05 mg/d
Dosage form
Film, Extended release
Route
Transdermal
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 203752
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers
Product ID 68968-6650_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

N468968665008 followed by a unit qualifier and the quantity

Package 68968-6650-08. 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)

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
ProductStrengthForm · routeLabelerProduct NDC
EstradiolEstradiol .0375 mg/dFilm, Extended releaseTransdermalA-S Medication Solutions50090-7610
EstradiolEstradiol .05 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-3450
EstradiolEstradiol .1 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-3410
EstradiolEstradiol .025 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-3425
EstradiolEstradiol .0375 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-3437
EstradiolEstradiol .075 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-3475
MinivelleestradiolEstradiol .025 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-6625
MinivelleestradiolEstradiol .1 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-6610
MinivelleestradiolEstradiol .0375 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-6637
MinivelleestradiolEstradiol .075 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-6675

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Minivelle (estradiol) NDC 68968-6650 | Med-Code