Julie
- Product NDC
- 82791-538
- 11-digit product format
- 827910538
- Labeler code
- 82791
- Product ID
- 82791-538_5ea0818f-2238-4f12-b58a-4bed37ef798b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Levonorgestrel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Julie Products Inc.
- Application
- ANDA206867
- Marketing category
- ANDA
- Marketing start
- 2022-07-15
- 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
- Julie
- 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, 2606549 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82791-538-01 | Julie | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 82791-538-01 | Julie | 1 in 1 BLISTER PACK | TABLET | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82791-538 | JULIE (LEVONORGESTREL) TABLET [JULIE PRODUCTS INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250409_8fb303ec-3b6a-47ac-9ad9-83ab6f0d6ae8.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 |
|---|
| 82791-538-01 | 82791053801 | 1 BLISTER PACK in 1 CARTON (82791-538-01) / 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2022-07-15 | 0000-00-00 | No | No | Current |