Prescription drug · ANDA
Cryselle (Norgestrel and ethinyl estradiol) NDC 0555-9049
Kit · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-9049-58 | 0055590495800555904958 | 6 POUCH in 1 CARTON (0555-9049-58) / 1 BLISTER PACK in 1 POUCH (0555-9049-79) / 1 KIT in 1 BLISTER PACKMarketed from Jul 24, 2002 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Cryselle
- Generic name (nonproprietary)
- norgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075840
- Marketing start
- Marketing end
- Identifiers
- Product ID 0555-9049_1fa9262a-8c57-4a86-b5aa-b331d1612fe2SPL ID 1fa9262a-8c57-4a86-b5aa-b331d1612fe2SPL set ID ee6be128-d494-4361-9a0d-341c0eee3587RxCUI 311359, 748797, 749786, 750265UPC 0305559049587
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.
- NDC on a medical claim
N400555904958followed by a unit qualifier and the quantityPackage 00555-9049-58. 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)
INDICATIONS AND USAGE Cryselle is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.
Excerpt only. Read the full label for complete information.
About NDC 0555-9049
- What is NDC 0555-9049?
- 0555-9049 is the product NDC for Cryselle kit, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cryselle (Norgestrel and Ethinyl Estradiol).
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cryselle?
- 4 other product NDCs are listed under this name. See all Cryselle NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cryselle products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Crysellenorgestrel and ethinyl estradiol | — | KitOral | Teva Pharmaceuticals, Inc. | 0480-3493 | 00480-3493-16 |
| Crysellenorgestrel and ethinyl estradiol | — | KitOral | A-S Medication Solutions | 50090-7917 | 50090-7917-00 |
| Crysellenorgestrel and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-2183 | 50090-2183-00 |
| Crysellenorgestrel and ethinyl estradiol | — | Kit | Proficient Rx LP | 71205-803 | 71205-0803-28 |
Other NDCs under ANDA 075840
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 |
|---|---|---|---|---|
| Crysellenorgestrel and ethinyl estradiol | — | KitOral | Teva Pharmaceuticals, Inc. | 0480-3493 |
| Crysellenorgestrel and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-2183 |
| Crysellenorgestrel and ethinyl estradiol | — | KitOral | A-S Medication Solutions | 50090-7917 |
| Crysellenorgestrel and ethinyl estradiol | — | Kit | Proficient Rx LP | 71205-803 |