Bijuva
- Product NDC
- 50261-211
- 11-digit product format
- 502610211
- Labeler code
- 50261
- Product ID
- 50261-211_fca91f4b-94dd-41c9-90c3-c50c4b2dcd76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol and progesterone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mayne Pharma LLC
- Application
- NDA210132
- Marketing category
- NDA
- Marketing start
- 2019-04-03
- Substance
- ESTRADIOL; PROGESTERONE
- Active strength
- 1; 100 mg/1; mg/1
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bijuva
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 1 mg/1 |
| PROGESTERONE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4G7DS2Q64Y, 4TI98Z838E |
| Rxcui | 2108924, 2108930, 2632844, 2632846 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50261-211 | BIJUVA (ESTRADIOL AND PROGESTERONE) CAPSULE [MAYNE PHARMA LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20250130_bc52489a-5149-411d-9665-2c75405ad15d.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 |
|---|
| 50261-211-05 | 50261021105 | 1 BLISTER PACK in 1 CARTON (50261-211-05) / 5 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2019-04-03 | 0000-00-00 | Yes | No | Current |
| 50261-211-30 | 50261021130 | 1 BLISTER PACK in 1 CARTON (50261-211-30) > 30 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2019-04-03 | 0000-00-00 | No | No | Current |