Prescription drug · NDA AUTHORIZED GENERIC
Estradiol Transdermal System (Estradiol) NDC 0781-7134
Estradiol .06 mg/d · Patch · Transdermal · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-7134-54 | 00781713454 | 4 PATCH in 1 CARTON (0781-7134-54) / 7 d in 1 PATCH (0781-7134-58)Marketed from Aug 31, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Transdermal System
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .06 mg/d
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020375
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0781-7134_1f2a1b63-ca41-4695-a296-542c1dc04b79SPL ID 1f2a1b63-ca41-4695-a296-542c1dc04b79SPL set ID c714974b-766f-42f2-a846-b0c1f5a60560RxCUI 238003, 238004, 241527, 242333, 403922, 403923UNII 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
N400781713454followed by a unit qualifier and the quantityPackage 00781-7134-54. 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)
The Estradiol Transdermal System is indicated for: 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause [Enter Generic Section here] 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation 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. 1.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure [Enter Generic Section here] 1.4 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, firs…
Excerpt only. Read the full label for complete information.
About NDC 0781-7134
- What is NDC 0781-7134?
- 0781-7134 is the product NDC for Estradiol Transdermal System (estradiol), Estradiol .06 mg/d patch, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estradiol Transdermal System (Estradiol).
- What is the active ingredient?
- Estradiol.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. 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 Transdermal System?
- 5 other product NDCs are listed under this name. See all Estradiol Transdermal System NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Estradiol Transdermal System 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 Transdermal Systemestradiol | Estradiol .0375 mg/d | PatchTransdermal | Sandoz Inc | 0781-7122 | 00781-7122-54 |
| Estradiol Transdermal Systemestradiol | Estradiol .025 mg/d | PatchTransdermal | Sandoz Inc | 0781-7119 | 00781-7119-54 |
| Estradiol Transdermal Systemestradiol | Estradiol .075 mg/d | PatchTransdermal | Sandoz Inc | 0781-7136 | 00781-7136-54 |
| Estradiol Transdermal Systemestradiol | Estradiol .1 mg/d | PatchTransdermal | Sandoz Inc | 0781-7104 | 00781-7104-54 |
| Estradiol Transdermal Systemestradiol | Estradiol .05 mg/d | PatchTransdermal | Sandoz Inc | 0781-7133 | 00781-7133-54 |
Other NDCs under NDA 020375
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 |
|---|---|---|---|---|
| Climaraestradiol | Estradiol .05 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-451 |
| Climaraestradiol | Estradiol .1 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-452 |
| Climaraestradiol | Estradiol .075 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-453 |
| Climaraestradiol | Estradiol .025 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-454 |
| Climaraestradiol | Estradiol .0375 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-456 |
| Climaraestradiol | Estradiol .06 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-459 |
| Estradiol Transdermal Systemestradiol | Estradiol .1 mg/d | PatchTransdermal | Sandoz Inc | 0781-7104 |
| Estradiol Transdermal Systemestradiol | Estradiol .025 mg/d | PatchTransdermal | Sandoz Inc | 0781-7119 |
| Estradiol Transdermal Systemestradiol | Estradiol .0375 mg/d | PatchTransdermal | Sandoz Inc | 0781-7122 |
| Estradiol Transdermal Systemestradiol | Estradiol .05 mg/d | PatchTransdermal | Sandoz Inc | 0781-7133 |
| Estradiol Transdermal Systemestradiol | Estradiol .075 mg/d | PatchTransdermal | Sandoz Inc | 0781-7136 |
| Menostarestradiol | Estradiol 14 ug/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-455 |