Prescription drug · NDA AUTHORIZED GENERIC

Estradiol NDC 68968-3437

Estradiol .0375 mg/d · Film, Extended release · Transdermal · Noven Therapeutics, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)68968-3437Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68968-3437Add 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
68968-3437-868968343708689683437088 POUCH in 1 CARTON (68968-3437-8) / 1 d in 1 POUCHMarketed from Jan 1, 2018

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)
Estradiol
Generic name (nonproprietary)
estradiol
Active ingredients
Estradiol — .0375 mg/d
Dosage form
Film, Extended release
Route
Transdermal
Labeler
Noven Therapeutics, LLCNDC labeler code 68968
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 203752
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers
Product ID 68968-3437_4d2e5c5f-d82f-4a2c-bfa5-2899fb283696SPL ID 4d2e5c5f-d82f-4a2c-bfa5-2899fb283696SPL set ID bf185599-2138-4083-9c52-2b95dce09ae0RxCUI 241946, 242891, 242892, 248478, 1149632UNII 4TI98Z838E
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

N468968343708 followed by a unit qualifier and the quantity

Package 68968-3437-08. 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)

ESTRADIOL TRANSDERMAL SYSTEM is indicated for: ESTRADIOL TRANSDERMAL SYSTEM is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) Prevention of postmenopausal osteoporosis ( 1.2 ) Limitation 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-estro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68968-3437

What is NDC 68968-3437?
68968-3437 is the product NDC for Estradiol, Estradiol .0375 mg/d film, 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?
Estradiol.
What is the active ingredient?
Estradiol.
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 Estradiol?
185 other product NDCs are listed under this name. See all Estradiol NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Estradiol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EstradiolEstradiol .75 mg/1.25gGelTransdermalEncube Ethicals, Inc.21922-01521922-0015-40
EstradiolEstradiol .75 mg/1.25gGelTopicalSolaris Pharma Corporation73473-30873473-0308-50
EstradiolEstradiol .5 mg/1TabletOralDirect_Rx72189-65572189-0655-60
EstradiolEstradiol .5 mg/1TabletOralCoupler LLC67046-156867046-1568-03
EstradiolEstradiol 1 mg/1TabletOralAmerican Health Packaging60687-87660687-0876-65
EstradiolEstradiol 1 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-886068788-8860-0168788-8860-0368788-8860-06+1 more
EstradiolEstradiol .75 mg/1.25gGel, MeteredTopicalANI Pharmaceuticals, Inc.70954-64670954-0646-10
Estradiolestradiol transdermalEstradiol 1 mg/gGelTopicalAmneal Pharmaceuticals NY LLC69238-244969238-2449-03
Estradiolestradiol transdermalEstradiol 1.25 mg/1.25gGelTopicalAmneal Pharmaceuticals NY LLC69238-244869238-2448-03
Estradiolestradiol transdermalEstradiol .25 mg/.25gGelTopicalAmneal Pharmaceuticals NY LLC69238-245269238-2452-03

All 186 Estradiol NDCs

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 .1 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-3410
EstradiolEstradiol .025 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-3425
EstradiolEstradiol .05 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-3450
EstradiolEstradiol .075 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-3475
MinivelleestradiolEstradiol .1 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-6610
MinivelleestradiolEstradiol .025 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-6625
MinivelleestradiolEstradiol .0375 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-6637
MinivelleestradiolEstradiol .05 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-6650
MinivelleestradiolEstradiol .075 mg/dFilm, Extended releaseTransdermalNoven Therapeutics, LLC68968-6675

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