Prescription drug · ANDA
Estradiol NDC 70710-1194
Estradiol .075 mg/d · Patch, Extended release · Transdermal · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1194-8 | 70710119408 | 8 POUCH in 1 BOX (70710-1194-8) / 1 PATCH in 1 POUCH (70710-1194-1) / 3.5 d in 1 PATCHMarketed from Apr 13, 2023 |
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 — .075 mg/d
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206241
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70710-1194_51a2adf6-a381-42cb-bf3e-8c83a7cfe738SPL ID 51a2adf6-a381-42cb-bf3e-8c83a7cfe738SPL set ID 839fe7ae-6835-4d6a-b6b1-ca7f062caa4fRxCUI 241946, 242891, 242892, 248478, 1149632UNII 4TI98Z838EUPC 0370710119188, 0370710119485, 0370710119287
- 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
N470710119408followed by a unit qualifier and the quantityPackage 70710-1194-08. 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)
Estradiol transdermal system, USP (twice-weekly) is indicated for: Estradiol transdermal system, USP (twice-weekly) 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 ost…
Excerpt only. Read the full label for complete information.
About NDC 70710-1194
- What is NDC 70710-1194?
- 70710-1194 is the product NDC for Estradiol, Estradiol .075 mg/d patch, extended release, 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 70710. 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?
- 181 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.
Related NDCs: other Estradiol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Estradiol | Estradiol .75 mg/1.25g | GelTransdermal | Encube Ethicals, Inc. | 21922-015 | 21922-0015-40 |
| Estradiol | Estradiol .75 mg/1.25g | GelTopical | Solaris Pharma Corporation | 73473-308 | 73473-0308-50 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Direct_Rx | 72189-655 | 72189-0655-60 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Coupler LLC | 67046-1568 | 67046-1568-03 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | American Health Packaging | 60687-876 | 60687-0876-65 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8860 | 68788-8860-0168788-8860-0368788-8860-06+1 more |
| Estradiol | Estradiol .75 mg/1.25g | Gel, MeteredTopical | ANI Pharmaceuticals, Inc. | 70954-646 | 70954-0646-10 |
| Estradiolestradiol transdermal | Estradiol 1.25 mg/1.25g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2448 | 69238-2448-03 |
| Estradiolestradiol transdermal | Estradiol 1 mg/g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2449 | 69238-2449-03 |
| Estradiolestradiol transdermal | Estradiol .75 mg/.75g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2450 | 69238-2450-03 |
Other NDCs under ANDA 206241
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 | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1563 |
| Estradiol | Estradiol .0375 mg/d | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1564 |
| Estradiol | Estradiol .05 mg/d | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1565 |
| Estradiol | Estradiol .075 mg/d | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1566 |
| Estradiol | Estradiol .1 mg/d | Patch, Extended releaseTransdermal | Zydus Lifesciences Limited | 70771-1567 |
| Estradiol | Estradiol .025 mg/d | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1191 |
| Estradiol | Estradiol .0375 mg/d | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1192 |
| Estradiol | Estradiol .05 mg/d | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1193 |
| Estradiol | Estradiol .1 mg/d | Patch, Extended releaseTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1195 |