Prescription drug · ANDA

Dotti (Estradiol) NDC 65162-997

Estradiol .1 mg/d · Patch, Extended release · Transdermal · Amneal Pharmaceuticals LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)65162-997Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65162-0997Add 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
65162-997-08651620997088 POUCH in 1 CARTON (65162-997-08) / 1 d in 1 POUCH (65162-997-04)Marketed from Feb 4, 2019

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)
Dotti
Generic name (nonproprietary)
estradiol
Active ingredients
Estradiol — .1 mg/d
Dosage form
Patch, Extended release
Route
Transdermal
Labeler
Amneal Pharmaceuticals LLCNDC labeler code 65162
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 65162-997_d26f45d5-79c5-429a-bb0f-44c58fa0b569SPL ID d26f45d5-79c5-429a-bb0f-44c58fa0b569SPL set ID 53016d30-6b5f-49da-ac16-85ef415a5805RxCUI 241946, 242891, 242892, 248478, 1149632, 2110774, 2110777, 2110780, 2110783, 2110786UNII 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

N465162099708 followed by a unit qualifier and the quantity

Package 65162-0997-08. 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)

DOTTI is indicated for: DOTTI 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-estrogen medications. Consider estrogen therapy only …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65162-997

What is NDC 65162-997?
65162-997 is the product NDC for Dotti (estradiol), Estradiol .1 mg/d patch, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dotti (Estradiol).
What is the active ingredient?
Estradiol.
Who is the labeler?
Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dotti?
9 other product NDCs are listed under this name. See all Dotti 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 Dotti NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DottiestradiolEstradiol .025 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-98965162-0989-08
DottiestradiolEstradiol .0375 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-99265162-0992-08
DottiestradiolEstradiol .05 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-99365162-0993-08
DottiestradiolEstradiol .075 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-99565162-0995-08
DottiestradiolEstradiol .025 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-203272162-2032-02
DottiestradiolEstradiol .0375 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-203372162-2033-02
DottiestradiolEstradiol .05 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-203472162-2034-02
DottiestradiolEstradiol .075 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-203572162-2035-02
DottiestradiolEstradiol .1 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-203672162-2036-02

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
DottiestradiolEstradiol .025 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-989
DottiestradiolEstradiol .0375 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-992
DottiestradiolEstradiol .05 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-993
DottiestradiolEstradiol .075 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals LLC65162-995
DottiestradiolEstradiol .025 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-2032
DottiestradiolEstradiol .0375 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-2033
DottiestradiolEstradiol .05 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-2034
DottiestradiolEstradiol .075 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-2035
DottiestradiolEstradiol .1 mg/dPatch, Extended releaseTransdermalBryant Ranch Prepack72162-2036
EstradiolEstradiol .025 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals NY LLC69238-1629
EstradiolEstradiol .0375 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals NY LLC69238-1630
EstradiolEstradiol .05 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals NY LLC69238-1631
EstradiolEstradiol .075 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals NY LLC69238-1632
EstradiolEstradiol .1 mg/dPatch, Extended releaseTransdermalAmneal Pharmaceuticals NY LLC69238-1633

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