Prescription drug · ANDA
estradiol NDC 68382-325
Estradiol .0375 mg/d · Patch · Transdermal · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-325-04 | 68382032504 | 4 POUCH in 1 CARTON (68382-325-04) / 1 PATCH in 1 POUCH (68382-325-01) / 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 — .0375 mg/d
- Dosage form
- Patch
- Route
- Transdermal
- 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 68382-325_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
N468382032504followed by a unit qualifier and the quantityPackage 68382-0325-04. 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.
Other NDCs under ANDA 202985
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| estradiol | Estradiol .025 mg/d | PatchTransdermal | Zydus Pharmaceuticals USA Inc. | 68382-324 |
| estradiol | Estradiol .075 mg/d | PatchTransdermal | Zydus Pharmaceuticals USA Inc. | 68382-328 |
| estradiol | Estradiol .05 mg/d | PatchTransdermal | Zydus Pharmaceuticals USA Inc. | 68382-326 |
| estradiol | Estradiol .06 mg/d | PatchTransdermal | Zydus Pharmaceuticals USA Inc. | 68382-327 |
| estradiol | Estradiol .1 mg/d | PatchTransdermal | Zydus Pharmaceuticals USA Inc. | 68382-329 |
| estradiol | Estradiol .025 mg/d | PatchTransdermal | Zydus Lifesciences Limited | 70771-1401 |
| estradiol | Estradiol .06 mg/d | PatchTransdermal | Zydus Lifesciences Limited | 70771-1404 |
| estradiol | Estradiol .0375 mg/d | PatchTransdermal | Zydus Lifesciences Limited | 70771-1402 |
| estradiol | Estradiol .05 mg/d | PatchTransdermal | Zydus Lifesciences Limited | 70771-1403 |
| estradiol | Estradiol .075 mg/d | PatchTransdermal | Zydus Lifesciences Limited | 70771-1405 |
| estradiol | Estradiol .1 mg/d | PatchTransdermal | Zydus Lifesciences Limited | 70771-1406 |