Prescription drug · NDA
Climara Pro (Estradiol and levonorgestrel) NDC 50419-491
Estradiol .045 mg/d; Levonorgestrel .015 mg/d · Patch · Transdermal · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-491-04 | 50419049104 | 4 PATCH in 1 CARTON (50419-491-04) / 7 d in 1 PATCHMarketed from Nov 21, 2013 | |
| 50419-491-73 | 50419049173 | 1 PATCH in 1 CARTON (50419-491-73) / 7 d in 1 PATCHMarketed from Apr 12, 2017 |
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 Pro
- Generic name (nonproprietary)
- estradiol and levonorgestrel
- Active ingredients
- Estradiol — .045 mg/dLevonorgestrel — .015 mg/d
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021258
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 50419-491_9f4e7765-d4e7-4f36-9530-8b4444587214SPL ID 9f4e7765-d4e7-4f36-9530-8b4444587214SPL set ID 184d3092-7fc6-4375-816b-1ab06bb99cfdRxCUI 402250, 402252UNII 4TI98Z838E, 5W7SIA7YZW
- Pharmacologic class
- Estrogen; Progestin; Progestin-containing Intrauterine System
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
N450419049104followed by a unit qualifier and the quantityPackage 50419-0491-04. 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 Pro is indicated for: Climara Pro is an estrogen plus progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Prevention of Postmenopausal Osteoporosis ( 1.2 ) 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 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of …
Excerpt only. Read the full label for complete information.
About NDC 50419-491
- What is NDC 50419-491?
- 50419-491 is the product NDC for Climara Pro, Estradiol .045 mg/d; Levonorgestrel .015 mg/d patch, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Climara Pro (Estradiol and Levonorgestrel).
- What is the active ingredient?
- Estradiol, Levonorgestrel.
- Who is the labeler?
- Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Climara Pro?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.