Prescription drug · ANDA

Estradiol NDC 69238-1631

Estradiol .05 mg/d · Patch, Extended release · Transdermal · Amneal Pharmaceuticals NY LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)69238-1631Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-1631Add 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
69238-1631-7692381631078 POUCH in 1 CARTON (69238-1631-7) / 1 d in 1 POUCH (69238-1631-1)Marketed from Feb 4, 2019

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 — .05 mg/d
Dosage form
Patch, Extended release
Route
Transdermal
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211293
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers
Product ID 69238-1631_8c947a6b-764e-480e-889c-6576b5cf7708SPL ID 8c947a6b-764e-480e-889c-6576b5cf7708SPL set ID 0500ee9b-bf4a-4432-9afe-20a7d60a6fe5RxCUI 241946, 242891, 242892, 248478, 1149632UNII 4TI98Z838EUPC 0369238162912, 0369238163018
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

N469238163107 followed by a unit qualifier and the quantity

Package 69238-1631-07. 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) 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 vaginal atrophy, 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 osteoporosis, first consider the use of non-estroge…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211293

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

FDA NDC Directory listings under ANDA 211293
ProductStrengthForm · routeLabelerProduct NDC
EstradiolEstradiol .025 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals NY LLC69238-1629
EstradiolEstradiol .0375 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals NY LLC69238-1630
EstradiolEstradiol .075 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals NY LLC69238-1632
EstradiolEstradiol .1 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals NY LLC69238-1633
DottiestradiolEstradiol .025 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-2032
DottiestradiolEstradiol .075 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-2035
DottiestradiolEstradiol .0375 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-2033
DottiestradiolEstradiol .05 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-2034
DottiestradiolEstradiol .025 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-989
DottiestradiolEstradiol .1 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-2036
DottiestradiolEstradiol .075 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-995
DottiestradiolEstradiol .0375 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-992
DottiestradiolEstradiol .05 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-993
DottiestradiolEstradiol .1 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-997

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