Affodel
- Product NDC
- 79929-015
- 11-digit product format
- 799290015
- Labeler code
- 79929
- Product ID
- 79929-015_16aaf795-d546-9f9c-e063-6394a90a09c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Naari Pte. Limited
- Application
- ANDA206807
- Marketing category
- ANDA
- Marketing start
- 2024-05-31
- Substance
- NORETHINDRONE
- Active strength
- .35 mg/1
- Pharmacologic classes
- 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
- Affodel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NORETHINDRONE | .35 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | T18F433X4S |
| Rxcui | 198042, 748961 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 79929-015-07 | Affodel | 28 in 1 BLISTER PACK | TABLET | 28 | | 3 |
| 79929-015-07 | Affodel | 84 in 1 CARTON | TABLET | 84 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 79929-015 | AFFODEL (NORETHINDRONE) TABLET [NAARI PTE. LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240531_8ec64ec8-fbc9-440d-9838-654a605d57da.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 |
|---|
| 79929-015-07 | 79929001507 | 84 BLISTER PACK in 1 CARTON (79929-015-07) / 28 TABLET in 1 BLISTER PACK | 84 blister pack | 2024-05-31 | 0000-00-00 | No | No | Current |