Prescription drug · ANDA
Isibloom NDC 63629-2333
desogestrel and ethinyl estradiol · Kit · Bryant Ranch Prepack
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Isibloom
- Generic name (nonproprietary)
- desogestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202789
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-2333_c4f10760-aa41-4132-badd-4dcf0be4b361SPL ID c4f10760-aa41-4132-badd-4dcf0be4b361SPL set ID 4a8f278f-f505-4537-8deb-74e8927df8c6RxCUI 240707, 748797, 749848, 1866047
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Isibloom TM (desogestrel and ethinyl estradiol tablets) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets, 1,195 subjects completed …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202789
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 |
|---|---|---|---|---|
| Isibloomdesogestrel and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-113 |