Estarylla
- Product NDC
- 82804-158
- 11-digit product format
- 828040158
- Labeler code
- 82804
- Product ID
- 82804-158_7acde5ef-f457-4c47-897b-d048194c7d7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norgestimate and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Proficient Rx LP
- Application
- ANDA090794
- Marketing category
- ANDA
- Marketing start
- 2018-01-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Estarylla
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 240128, 748797, 749860, 1369737 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-158-28 | Estarylla | 1 in 1 BLISTER PACK | KIT | 1 | | 1 |
| 82804-158-28 | Estarylla | 1 in 1 POUCH | KIT | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-158 | ESTARYLLA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PROFICIENT RX LP] | 1 | Current NDC, 2 package rows | 20241017_7acde5ef-f457-4c47-897b-d048194c7d7e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-158-28 | 82804015828 | 1 BLISTER PACK in 1 POUCH (82804-158-28) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2024-10-07 | No | No | Current |