Prescription drug · ANDA
estradiol NDC 68382-323
Estradiol .014 mg/d · Patch · Transdermal · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-323-04 | 68382032304 | 4 POUCH in 1 CARTON (68382-323-04) / 1 PATCH in 1 POUCH (68382-323-01) / 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 — .014 mg/d
- Dosage form
- Patch
- Route
- Transdermal
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204379
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68382-323_1e54d575-0530-4304-8a50-3ffaf3c124d4SPL ID 1e54d575-0530-4304-8a50-3ffaf3c124d4SPL set ID 684850eb-d889-4370-a0a7-4a5c3113266aRxCUI 476545UNII 4TI98Z838EUPC 0368382323040
- 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
N468382032304followed by a unit qualifier and the quantityPackage 68382-0323-04. 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 is an estrogen indicated for: Prevention of Postmenopausal Osteoporosis ( 1.1 ) Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204379
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 .014 mg/d | PatchTransdermal | Zydus Lifesciences Limited | 70771-1400 |