ESTRADIOL AND NORETHINDRONE ACETATE
- Product NDC
- 0378-7294
- 11-digit product format
- 003787294
- Labeler code
- 0378
- Product ID
- 0378-7294_b24d133a-50ee-4fd6-926d-cac8f34e8ebd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol and norethindrone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA207261
- Marketing category
- ANDA
- Marketing start
- 2018-07-24
- Marketing end
- 0000-00-00
- Substance
- ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 1 mg/1; mg/1
- Pharmacologic classes
- Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7294 | ESTRADIOL AND NORETHINDRONE ACETATE TABLET [MYLAN PHARMACEUTICALS INC.] | 9 | Legacy NDC | 20250216_6cafe148-bfb8-4c09-a056-b0637c0c3065.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-7294-53 | 00378729453 | 3 POUCH in 1 CARTON (0378-7294-53) > 1 BLISTER PACK in 1 POUCH (0378-7294-85) > 28 TABLET in 1 BLISTER PACK | 3 pouch | 2018-07-24 | 0000-00-00 | No | No | Current |