Prescription drug · ANDA
Jaimiess NDC 63629-2345
levonorgestrel / ethinyl estradiol and ethinyl estradiol · Kit · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2345-1 | 6362923450163629234501 | 1 BLISTER PACK in 1 BOX (63629-2345-1) / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 2018 |
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)
- Jaimiess
- Generic name (nonproprietary)
- levonorgestrel / ethinyl estradiol 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 203770
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-2345_671c669b-22e7-439e-b6d5-80d90ddf9f97SPL ID 671c669b-22e7-439e-b6d5-80d90ddf9f97SPL set ID aa2f5907-8677-4688-af59-3903b32f9b21RxCUI 238019, 248310, 749761, 2001751
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
N463629234501followed by a unit qualifier and the quantityPackage 63629-2345-01. 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)
Jaimiess ® is indicated for use by women to prevent pregnancy. Jaimiess 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 63629-2345
- What is NDC 63629-2345?
- 63629-2345 is the product NDC for Jaimiess 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?
- Jaimiess (Levonorgestrel / ethinyl estradiol 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 Jaimiess?
- 2 other product NDCs are listed under this name. See all Jaimiess NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Jaimiess products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Jaimiesslevonorgestrel and ethinyl estradiol and ethinyl estradiol tablets | — | Kit | Xiromed LLC | 70700-206 | 70700-0206-93 |
| Jaimiesslevonorgestrel / ethinyl estradiol and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-123 | 70700-0123-87 |
Other NDCs under ANDA 203770
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 |
|---|---|---|---|---|
| Jaimiesslevonorgestrel / ethinyl estradiol and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-123 |