Norethindrone Acetate
- Product NDC
- 0378-7291
- 11-digit product format
- 003787291
- Labeler code
- 0378
- Product ID
- 0378-7291_7480bf8e-3dcd-4697-9f0f-924beb419ee9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA205278
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Marketing end
- 0000-00-00
- Substance
- NORETHINDRONE ACETATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- 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 |
|---|
| 0378-7291 | NORETHINDRONE ACETATE TABLET [MYLAN PHARMACEUTICALS INC.] | 5 | Legacy NDC | 20250221_4e8e531a-dac2-44ce-b06b-390296c26833.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-7291-89 | 00378729189 | 50 TABLET in 1 BOTTLE (0378-7291-89) | 50 tablet | 2019-07-19 | 0000-00-00 | No | No | Current |