Prescription drug · ANDA
Syeda (Drospirenone and ethinyl estradiol) NDC 63629-2335
Kit · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2335-1 | 63629233501 | 3 BLISTER PACK in 1 CARTON (63629-2335-1) / 1 KIT in 1 BLISTER PACKMarketed from Apr 27, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Syeda
- Generic name (nonproprietary)
- drospirenone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090114
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-2335_65492141-f6d8-4c3d-900a-e98fdd9fe27cSPL ID 65492141-f6d8-4c3d-900a-e98fdd9fe27cSPL set ID 4424505f-acae-43ba-8a75-eadd0e283b23RxCUI 284207, 748797, 748800, 1099269
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
N463629233501followed by a unit qualifier and the quantityPackage 63629-2335-01. 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)
Syeda ® (drospirenone and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. Syeda ® (drospirenone and ethinyl estradiol tablets) is an estrogen/progestin COC indicated for use by women to prevent pregnancy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 63629-2335
- What is NDC 63629-2335?
- 63629-2335 is the product NDC for Syeda kit, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Syeda (Drospirenone and Ethinyl Estradiol).
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Syeda?
- 1 other product NDC are listed under this name. See all Syeda NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Syeda products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Syedadrospirenone and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-115 | 70700-0115-85 |
Other NDCs under ANDA 090114
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 |
|---|---|---|---|---|
| Syedadrospirenone and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-115 |