My Way
- Product NDC
- 43386-622
- 11-digit product format
- 433860622
- Labeler code
- 43386
- Product ID
- 43386-622_6dce7821-019c-4344-9634-5a51060920d5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Levonorgestrel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA202508
- Marketing category
- ANDA
- Marketing start
- 2013-02-15
- 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 Device [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- My Way
- 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, 1426881 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-622-30 | My Way | 1 in 1 CARTON | TABLET | 1 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVONORGESTREL | ACTIVE INGREDIENT | 5W7SIA7YZW | MY WAY (LEVONORGESTREL) TABLET [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| LEVONORGESTREL | ACTIVE MOIETY | 5W7SIA7YZW | MY WAY (LEVONORGESTREL) TABLET [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MY WAY (LEVONORGESTREL) TABLET [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MY WAY (LEVONORGESTREL) TABLET [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MY WAY (LEVONORGESTREL) TABLET [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MY WAY (LEVONORGESTREL) TABLET [GAVIS PHARMACEUTICALS, LLC] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MY WAY (LEVONORGESTREL) TABLET [GAVIS PHARMACEUTICALS, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-622 | MY WAY (LEVONORGESTREL) TABLET [LUPIN PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20160629_ec01077e-ac3c-424a-9edc-0854fe0a2e0d.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 |
|---|
| 43386-622-30 | 43386062230 | 1 TABLET in 1 CARTON (43386-622-30) | 1 tablet | 2013-02-15 | 0000-00-00 | No | No | Current |