NDC 68180-830
AMABELZ
Estradiol And Norethindrone Acetate
AMABELZ is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Estradiol; Norethindrone.
| Product ID | 68180-830_28ead69b-4f95-4528-9c17-a0eca870cf0d |
| NDC | 68180-830 |
| Product Type | Human Prescription Drug |
| Proprietary Name | AMABELZ |
| Generic Name | Estradiol And Norethindrone Acetate |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-10-08 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203339 |
| Labeler Name | Lupin Pharmaceuticals, Inc. |
| Substance Name | ESTRADIOL; NORETHINDRONE |
| Active Ingredient Strength | 1 mg/1; mg/1 |
| Pharm Classes | Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 68180-830-73
3 POUCH in 1 CARTON (68180-830-73) > 1 BLISTER PACK in 1 POUCH (68180-830-71) > 28 TABLET in 1 BLISTER PACK
| Marketing Start Date | 2020-10-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 68180-830-11 [68180083011]
AMABELZ TABLET
| Marketing Category | ANDA |
| Application Number | ANDA203339 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-10-21 |
NDC 68180-830-13 [68180083013]
AMABELZ TABLET
| Marketing Category | ANDA |
| Application Number | ANDA203339 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-10-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ESTRADIOL | 1 mg/1 |
OpenFDA Data
| SPL SET ID: | 3b8a7426-6f1c-470a-ac36-b8465b8679cd |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Estradiol Congeners [CS]
- Estrogen [EPC]
- Estrogen Receptor Agonists [MoA]
- Progesterone Congeners [CS]
- Progestin [EPC]
Medicade Reported Pricing
68180083013 AMABELZ 1 MG-0.5 MG TABLET
Pricing Unit: EA | Drug Type:
68180083011 AMABELZ 1 MG-0.5 MG TABLET
Pricing Unit: EA | Drug Type:
NDC Crossover Matching brand name "AMABELZ" or generic name "Estradiol And Norethindrone Acetate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68180-829 | AMABELZ | estradiol and norethindrone acetate |
| 68180-830 | AMABELZ | estradiol and norethindrone acetate |
| 60846-201 | Activella | estradiol and norethindrone acetate |
| 60846-202 | Activella | estradiol and norethindrone acetate |
| 51991-474 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate |
| 51991-623 | Estradiol / Norethindrone Acetate | Estradiol and Norethindrone Acetate |
| 0378-7294 | ESTRADIOL AND NORETHINDRONE ACETATE | estradiol and norethindrone acetate |
| 0378-7295 | ESTRADIOL AND NORETHINDRONE ACETATE | estradiol and norethindrone acetate |
| 50742-657 | Estradiol and Norethindrone Acetate | Estradiol and Norethindrone Acetate |
| 50742-658 | Estradiol and Norethindrone Acetate | Estradiol and Norethindrone Acetate |
| 0093-5455 | Mimvey | Estradiol and Norethindrone Acetate |
| 0093-5454 | Mimvey Lo | Estradiol and Norethindrone Acetate |
Trademark Results [AMABELZ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMABELZ 87100819 5287570 Live/Registered |
Lupin Limited 2016-07-12 |
 AMABELZ 85830099 not registered Dead/Abandoned |
Lupin Limited 2013-01-23 |
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