Prescription drug · NDA
Climara (estradiol) NDC 50419-453
Estradiol .075 mg/d · Patch · Transdermal · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-453-04 | 50419045304 | 4 PATCH in 1 CARTON (50419-453-04) / 7 d in 1 PATCH (50419-453-01)Marketed from Mar 23, 1998 |
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)
- Climara
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .075 mg/d
- Dosage form
- Patch
- Route
- Transdermal
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020375
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 50419-453_c092f921-73f7-45be-b928-744cfdd24b49SPL ID c092f921-73f7-45be-b928-744cfdd24b49SPL set ID 1e9702c4-f2d7-4ea8-b6e8-7dca31671864RxCUI 238003, 238004, 241527, 242333, 310170, 310174, 310178, 310181, 403922, 403923, 404656, 404657UNII 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
N450419045304followed by a unit qualifier and the quantityPackage 50419-0453-04. 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)
Climara is indicated for: Climara 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 osteoporosis, first consider the use of non-es…
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| 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 .06 mg/d | PatchTransdermal | Sandoz Inc | 0781-7134 |
| Estradiol Transdermal Systemestradiol | Estradiol .075 mg/d | PatchTransdermal | Sandoz Inc | 0781-7136 |
| Climaraestradiol | Estradiol .1 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-452 |
| Climaraestradiol | Estradiol .05 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-451 |
| Climaraestradiol | Estradiol .0375 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-456 |
| Climaraestradiol | Estradiol .025 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-454 |
| Menostarestradiol | Estradiol 14 ug/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-455 |
| Climaraestradiol | Estradiol .06 mg/d | PatchTransdermal | Bayer HealthCare Pharmaceuticals Inc. | 50419-459 |