Prescription drug · NDA
Angeliq (Drospirenone and estradiol) NDC 50419-482
Estradiol .5 mg/1; Drospirenone .25 mg/1 · Tablet, Film coated · Oral · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-482-03 | 50419048203 | 3 BLISTER PACK in 1 CARTON (50419-482-03) / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-01)Marketed from Feb 29, 2012 | |
| 50419-482-72 | 50419048272 | 1 BLISTER PACK in 1 CARTON (50419-482-72) / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-71)Marketed from Feb 29, 2012 |
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)
- Angeliq
- Generic name (nonproprietary)
- drospirenone and estradiol
- Active ingredients
- Estradiol — .5 mg/1Drospirenone — .25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021355
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 50419-482_261d4ace-5c4e-48f6-b793-354492017e89SPL ID 261d4ace-5c4e-48f6-b793-354492017e89SPL set ID 761834c2-6b61-4583-84c2-f1ca4a97c4f2RxCUI 1483549, 1483550, 1483551, 1483552, 1483553, 1483554UNII N295J34A25, 4TI98Z838E
- Pharmacologic class
- Estrogen; Progestin
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450419048203followed by a unit qualifier and the quantityPackage 50419-0482-03. 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)
Use estrogen, alone or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Re-evaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary. Angeliq is a combination of an estrogen and progestin indicated in a woman with a uterus for the treatment of: Moderate to severe vasomotor symptoms due to menopause. ( 1.1 ) Moderate to severe vulvar and vaginal atrophy symptoms due to menopause. ( 1.2 ) Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the…
Excerpt only. Read the full label for complete information.
About NDC 50419-482
- What is NDC 50419-482?
- 50419-482 is the product NDC for Angeliq, Estradiol .5 mg/1; Drospirenone .25 mg/1 tablet, film coated, 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?
- Angeliq (Drospirenone and estradiol).
- What is the active ingredient?
- Estradiol, Drospirenone.
- 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 Angeliq?
- 1 other product NDC are listed under this name. See all Angeliq NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Angeliq products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Angeliqdrospirenone and estradiol | Estradiol 1 mg/1; Drospirenone .5 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-483 | 50419-0483-0350419-0483-72 |
Other NDCs under NDA 021355
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 |
|---|---|---|---|---|
| Angeliqdrospirenone and estradiol | Estradiol 1 mg/1; Drospirenone .5 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-483 |