Prescription drug · ANDA
Estarylla (Norgestimate and ethinyl estradiol) NDC 63629-2349
Kit · Bryant Ranch Prepack
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Estarylla
- Generic name (nonproprietary)
- norgestimate 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 090794
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-2349_d6d812f4-c411-4e65-9601-a9bc38acb028SPL ID d6d812f4-c411-4e65-9601-a9bc38acb028SPL set ID e0b07fb6-8dbd-4e5d-b589-5191a1dc02aeRxCUI 240128, 748797, 749860, 1369737
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)
Estarylla™ (norgestimate and ethinyl estradiol tablets, USP),are an estrogen/progestin COCs, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive Estarylla™ (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14) ] .
Excerpt only. Read the full label for complete information.
About NDC 63629-2349
- What is NDC 63629-2349?
- 63629-2349 is the product NDC for Estarylla kit, listed with the FDA by Bryant Ranch Prepack.
- What drug is associated with this NDC?
- Estarylla (Norgestimate 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 Estarylla?
- 2 other product NDCs are listed under this name. See all Estarylla NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Estarylla products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Estaryllanorgestimate and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-119 | 70700-0119-85 |
| Estaryllanorgestimate and ethinyl estradiol | — | Kit | Proficient Rx LP | 82804-158 | 82804-0158-28 |
Other NDCs under ANDA 090794
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 |
|---|---|---|---|---|
| Estaryllanorgestimate and ethinyl estradiol | — | Kit | Proficient Rx LP | 82804-158 |
| Estaryllanorgestimate and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-119 |
| Norgestimate and Ethinyl Estradiol | — | Kit | AvKARE | 42291-553 |