Estradiol / Norethindrone Acetate
- Product NDC
- 51991-623
- 11-digit product format
- 519910623
- Labeler code
- 51991
- Product ID
- 51991-623_d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol and Norethindrone Acetate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA078324
- Marketing category
- ANDA
- Marketing start
- 2011-06-09
- 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
- Estradiol / Norethindrone Acetate
- 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 | 4TI98Z838E, 9S44LIC7OJ |
| Rxcui | 1359123, 1359124, 1359126, 1359127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51991-623-28 | Estradiol / Norethindrone Acetate | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 10 |
| 51991-623-28 | Estradiol / Norethindrone Acetate | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-623 | ESTRADIOL / NORETHINDRONE ACETATE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240327_44125b2f-10ac-435c-bdb4-a29bf8450dbf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51991-623-28 | 51991062328 | 1 BLISTER PACK in 1 CARTON (51991-623-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2011-06-09 | 0000-00-00 | No | No | Current |