Mimvey
- Product NDC
- 0093-5455
- 11-digit product format
- 000935455
- Labeler code
- 0093
- Product ID
- 0093-5455_2704fcb9-da21-461e-b6ba-b196b2f2bf4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol and Norethindrone Acetate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA079193
- Marketing category
- ANDA
- Marketing start
- 2010-06-02
- 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
- Mimvey
- 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, 1359129 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-5455-28 | Mimvey | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 16 |
| 0093-5455-28 | Mimvey | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 16 |
| 0093-5455-42 | Mimvey | 5 in 1 CARTON | TABLET, FILM COATED | 5 | | 16 |
| 0093-5455-42 | Mimvey | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| NORETHINDRONE ACETATE | ACTIVE INGREDIENT | 9S44LIC7OJ | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| NORETHINDRONE | ACTIVE MOIETY | T18F433X4S | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED MIMVEY LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [TEVA PHARMACEUTICALS USA INC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-5455 | MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 16 | Current NDC, Legacy NDC, 4 package rows | 20240719_b1c5c06b-9ce2-4bf7-9693-e37608055a14.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 |
|---|
| 0093-5455-28 | 00093545528 | 1 BLISTER PACK in 1 CARTON (0093-5455-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2010-06-02 | 0000-00-00 | No | No | Current |
| 0093-5455-42 | 00093545542 | 5 BLISTER PACK in 1 CARTON (0093-5455-42) / 28 TABLET, FILM COATED in 1 BLISTER PACK | 5 blister pack | 2010-06-02 | 0000-00-00 | No | No | Current |