AMABELZ
- Product NDC
- 68180-830
- 11-digit product format
- 681800830
- Labeler code
- 68180
- Product ID
- 68180-830_ea126b9d-ba9c-454e-9dda-c13552b42d0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol and norethindrone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA203339
- Marketing category
- ANDA
- Marketing start
- 2020-10-08
- Marketing end
- 0000-00-00
- Substance
- ESTRADIOL; NORETHINDRONE
- Active strength
- 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
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-830-13 | 68180083013 | 3 POUCH in 1 CARTON (68180-830-13) > 1 BLISTER PACK in 1 POUCH (68180-830-11) > 28 TABLET in 1 BLISTER PACK | 3 pouch | 2016-10-21 | 2022-04-30 | No | No | Current |
| 68180-830-73 | 68180083073 | 3 POUCH in 1 CARTON (68180-830-73) > 1 BLISTER PACK in 1 POUCH (68180-830-71) > 28 TABLET in 1 BLISTER PACK | 3 pouch | 2020-10-08 | 0000-00-00 | No | No | Current |