Tri-Estarylla
- Product NDC
- 63629-2350
- 11-digit product format
- 636292350
- Labeler code
- 63629
- Product ID
- 63629-2350_74936d25-1b06-4b3b-9e6d-9ba409a060fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norgestimate and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090793
- Marketing category
- ANDA
- Marketing start
- 2022-09-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tri-Estarylla
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 240128, 406396, 687424, 748797, 749784, 1369770 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-2350-1 | Tri-Estarylla | 3 in 1 CARTON | KIT | 3 | 104 | |
| 63629-2350-1 | Tri-Estarylla | 1 in 1 BLISTER PACK | KIT | 1 | 104 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-2350-1 | EA - Each | 63629-2350 | 8dc96fcc-3ee9-4672-aceb-0ecdfd47f4ec | 1 | 2021-07-15 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-2350 | TRI-ESTARYLLA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 2 package rows | 20240523_6560d15f-6ce9-4f0e-9b59-043dec35ddd9.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1369770 | {7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Tri-Estarylla 28 Day] | BPCK | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 749784 | {7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 749784 | Eth estra-Norgestim 0.035-0.18 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.215 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 748797 | inert 1 MG Oral Tablet | PSN | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 406396 | norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 687424 | norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 240128 | norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet | PSN | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 1369770 | Tri-Estarylla 28 Day Pack | PSN | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 406396 | ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet | SCD | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 687424 | ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet | SCD | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 240128 | ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet | SCD | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 240128 | ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet | SY | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
| 1369770 | Tri-Estarylla 28 Day Pack | SY | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 104 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-2350-1 | 63629235001 | 3 BLISTER PACK in 1 CARTON (63629-2350-1) / 1 KIT in 1 BLISTER PACK | 3 blister pack | 2023-02-10 | 0000-00-00 | No | No | Current |