Etyqa
- Product NDC
- 59651-425
- 11-digit product format
- 596510425
- Labeler code
- 59651
- Product ID
- 59651-425_50c8c596-e201-4370-8487-421925c60b4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESTRADIOL AND NORETHINDRONE ACETATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA214729
- Marketing category
- ANDA
- Marketing start
- 2023-06-30
- Substance
- ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- .5; .1 mg/1; mg/1
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Etyqa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | .5 mg/1 |
| NORETHINDRONE ACETATE | .1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9S44LIC7OJ, 4TI98Z838E |
| Rxcui | 1359123, 1359124, 1359126, 1359127, 2642136, 2642137 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-425-28 | Etyqa | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 2 |
| 59651-425-28 | Etyqa | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 59651-425-87 | Etyqa | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 2 |
| 59651-425-87 | Etyqa | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-425 | ETYQA (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 4 package rows | 20240308_afbc2a33-5eb2-4f01-91e9-07d8050da6ce.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 |
|---|
| 59651-425-28 | 59651042528 | 1 BLISTER PACK in 1 CARTON (59651-425-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2023-06-30 | No | No | Current |
| 59651-425-87 | 59651042587 | 1 POUCH in 1 CARTON (59651-425-87) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK | 1 pouch | 2023-06-30 | No | No | Current |