ITHAPPENZ MORNING AFTER
- Product NDC
- 58602-892
- 11-digit product format
- 586020892
- Labeler code
- 58602
- Product ID
- 58602-892_6c3a0c42-b783-4b9f-a801-7b128ae38ff4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Levonorgestrel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA206867
- Marketing category
- ANDA
- Marketing start
- 2022-11-14
- Substance
- LEVONORGESTREL
- Active strength
- 1.5 mg/1
- Pharmacologic classes
- Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ITHAPPENZ MORNING AFTER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVONORGESTREL | 1.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5W7SIA7YZW |
| Rxcui | 483325, 2632742 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-892-57 | ITHAPPENZ MORNING AFTER | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
| 58602-892-57 | ITHAPPENZ MORNING AFTER | 1 in 1 CARTON | TABLET | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-892 | ITHAPPENZ MORNING AFTER (LEVONORGESTREL) TABLET [AUROHEALTH LLC] | 3 | Current NDC, 2 package rows | 20250409_5ee40793-0121-4b8f-b20d-3178bbe262e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58602-892-57 | 58602089257 | 1 BLISTER PACK in 1 CARTON (58602-892-57) / 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2022-11-14 | No | No | Current |