ESTRADIOL AND NORETHINDRONE ACETATE
- Product NDC
- 79929-012
- 11-digit product format
- 799290012
- Labeler code
- 79929
- Product ID
- 79929-012_1a990fcf-1731-8ca1-e063-6294a90ac9c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol and norethindrone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Naari Pte. Limited
- Application
- ANDA210233
- Marketing category
- ANDA
- Marketing start
- 2024-06-11
- Substance
- ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 1; .5 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
- ESTRADIOL AND NORETHINDRONE ACETATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 1 mg/1 |
| NORETHINDRONE ACETATE | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E, 9S44LIC7OJ |
| Rxcui | 1359126, 1359127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 79929-012-07 | ESTRADIOL AND NORETHINDRONE ACETATE | 84 in 1 POUCH | TABLET | 84 | | 5 |
| 79929-012-07 | ESTRADIOL AND NORETHINDRONE ACETATE | 28 in 1 BLISTER PACK | TABLET | 28 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 79929-012 | ESTRADIOL AND NORETHINDRONE ACETATE TABLET [NAARI PTE. LIMITED] | 5 | Current NDC, 2 package rows | 20240612_f70185fe-9fcf-655f-e053-6394a90a20dc.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 |
|---|
| 79929-012-07 | 79929001207 | 84 BLISTER PACK in 1 POUCH (79929-012-07) / 28 TABLET in 1 BLISTER PACK | 84 blister pack | 2024-06-11 | No | No | Historical |