Prescription drug · ANDA
Cryselle (Norgestrel and ethinyl estradiol) NDC 0480-3493
Kit · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3493-16 | 0048034931600480349316 | 6 POUCH in 1 CARTON (0480-3493-16) / 1 BLISTER PACK in 1 POUCH (0480-3493-24) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22)Marketed from Dec 12, 2025 |
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
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075840
- Marketing start
- Listing expires
- Identifiers
- Product ID 0480-3493_12ff0377-5119-422a-a2f6-677d5fc38078SPL ID 12ff0377-5119-422a-a2f6-677d5fc38078
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
N400480349316followed by a unit qualifier and the quantityPackage 00480-3493-16. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0480-3493
- What is NDC 0480-3493?
- 0480-3493 is the product NDC for Cryselle kit, listed with the FDA by Teva Pharmaceuticals, 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, Inc., NDC labeler code 0480. 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 | A-S Medication Solutions | 50090-7917 | 50090-7917-00 |
| Crysellenorgestrel and ethinyl estradiol | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9049 | 00555-9049-58 |
| 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 | — | Kit | Teva Pharmaceuticals USA, Inc. | 0555-9049 |
| 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 |