NDC codes

FDA NDC Directory
Product NDC (as listed)50419-491Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50419-0491Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50419-491-04504190491044 PATCH in 1 CARTON (50419-491-04) / 7 d in 1 PATCHMarketed from Nov 21, 2013
50419-491-73504190491731 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

N450419049104 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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