Prescription drug · ANDA

estradiol NDC 68382-326

Estradiol .05 mg/d · Patch · Transdermal · Zydus Pharmaceuticals USA Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68382-326Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0326Add 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
68382-326-0468382032604683820326044 POUCH in 1 CARTON (68382-326-04) / 1 PATCH in 1 POUCH (68382-326-01) / 7 d in 1 PATCHMarketed from Nov 2, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — .05 mg/d
Dosage form
Patch
Route
Transdermal
Labeler
Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202985
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers
Product ID 68382-326_bc6ecc76-9efc-435a-ac21-b526a971c343SPL ID bc6ecc76-9efc-435a-ac21-b526a971c343SPL set ID db4696da-7820-4b2b-97b4-fb05b1208020RxCUI 238003, 238004, 241527, 242333, 403922, 403923UNII 4TI98Z838EUPC 0368382328045, 0368382327048, 0368382324047, 0368382329042, 0368382326041
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

N468382032604 followed by a unit qualifier and the quantity

Package 68382-0326-04. 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, USP is an estrogen indicated for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) Limitations of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ( 1.3 ) Prevention of Postmenopausal Osteoporosis ( 1.4 ) Limitations of Use When prescribing solely for the prevention of postmenopausal…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-326

What is NDC 68382-326?
68382-326 is the product NDC for estradiol, Estradiol .05 mg/d patch, listed with the FDA by Zydus Pharmaceuticals USA Inc.. 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?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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?
182 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 1.25 mg/1.25gGelTopicalAmneal Pharmaceuticals NY LLC69238-244869238-2448-03
Estradiolestradiol transdermalEstradiol 1 mg/gGelTopicalAmneal Pharmaceuticals NY LLC69238-244969238-2449-03
Estradiolestradiol transdermalEstradiol .75 mg/.75gGelTopicalAmneal Pharmaceuticals NY LLC69238-245069238-2450-03

All 183 estradiol NDCs

Other NDCs under ANDA 202985

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

FDA NDC Directory listings under ANDA 202985
ProductStrengthForm · routeLabelerProduct NDC
estradiolEstradiol .025 mg/dPatchTransdermalZydus Pharmaceuticals USA Inc.68382-324
estradiolEstradiol .0375 mg/dPatchTransdermalZydus Pharmaceuticals USA Inc.68382-325
estradiolEstradiol .06 mg/dPatchTransdermalZydus Pharmaceuticals USA Inc.68382-327
estradiolEstradiol .075 mg/dPatchTransdermalZydus Pharmaceuticals USA Inc.68382-328
estradiolEstradiol .1 mg/dPatchTransdermalZydus Pharmaceuticals USA Inc.68382-329
estradiolEstradiol .025 mg/dPatchTransdermalZydus Lifesciences Limited70771-1401
estradiolEstradiol .0375 mg/dPatchTransdermalZydus Lifesciences Limited70771-1402
estradiolEstradiol .05 mg/dPatchTransdermalZydus Lifesciences Limited70771-1403
estradiolEstradiol .06 mg/dPatchTransdermalZydus Lifesciences Limited70771-1404
estradiolEstradiol .075 mg/dPatchTransdermalZydus Lifesciences Limited70771-1405
estradiolEstradiol .1 mg/dPatchTransdermalZydus Lifesciences Limited70771-1406

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