Prescription drug · ANDA
Tri-Estarylla (Norgestimate and ethinyl estradiol) NDC 63629-2350
Kit · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2350-1 | 63629235001 | 3 BLISTER PACK in 1 CARTON (63629-2350-1) / 1 KIT in 1 BLISTER PACKMarketed from Feb 10, 2023 |
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)
- Tri-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 090793
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-2350_74936d25-1b06-4b3b-9e6d-9ba409a060fcSPL ID 74936d25-1b06-4b3b-9e6d-9ba409a060fcSPL set ID 6560d15f-6ce9-4f0e-9b59-043dec35ddd9RxCUI 240128, 406396, 687424, 748797, 749784, 1369770
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
N463629235001followed by a unit qualifier and the quantityPackage 63629-2350-01. 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)
Tri-Estarylla (norgestimate and ethinyl estrdiol tablets) is a combinations of norgestimate, a progestin, and ethinyl estradiol, and estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) Tri-Estarylla is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-Estarylla (norgestimate and ethinyl estradiol) Tablets are indicated for use by females of reproductive potenti…
Excerpt only. Read the full label for complete information.
About NDC 63629-2350
- What is NDC 63629-2350?
- 63629-2350 is the product NDC for Tri-Estarylla 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?
- Tri-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 Tri-Estarylla?
- 2 other product NDCs are listed under this name. See all Tri-Estarylla NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tri-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) |
|---|---|---|---|---|---|
| Tri-Estaryllanorgestimate and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-7861 | 50090-7861-00 |
| Tri-Estaryllanorgestimate and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-121 | 70700-0121-85 |
Other NDCs under ANDA 090793
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 |
|---|---|---|---|---|
| norgestimate and ethinyl estradiol | — | Kit | AvKARE | 42291-590 |
| Tri-Estaryllanorgestimate and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-7861 |
| Tri-Estaryllanorgestimate and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-121 |