LUIZZA 1.5/30
- Product NDC
- 70700-314
- 11-digit product format
- 707000314
- Labeler code
- 70700
- Product ID
- 70700-314_689d38d7-80e3-b31c-396d-313bccdf7b33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone acetate and ethinyl estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Xiromed LLC
- Application
- ANDA202770
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 30; 1.5 ug/1; mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], 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
- LUIZZA 1.5/30
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 30 ug/1 |
| NORETHINDRONE ACETATE | 1.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1359022, 1359028, 2712092 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70700-314-78 | LUIZZA 1.5/30 | 1 in 1 POUCH | TABLET | 1 | | 1 |
| 70700-314-78 | LUIZZA 1.5/30 | 21 in 1 BLISTER PACK | TABLET | 21 | | 1 |
| 70700-314-79 | LUIZZA 1.5/30 | 3 in 1 CARTON | TABLET | 3 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70700-314 | LUIZZA 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [XIROMED LLC] | 1 | Current NDC, 3 package rows | 20250418_b1c3e33d-ec95-cd89-7ad9-36994c802a1f.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 |
|---|
| 70700-314-78 | 70700031478 | 1 in 1 POUCH | | | | | Historical |
| 70700-314-79 | 70700031479 | 3 POUCH in 1 CARTON (70700-314-79) / 1 BLISTER PACK in 1 POUCH (70700-314-78) / 21 TABLET in 1 BLISTER PACK | 3 pouch | 2025-01-29 | No | No | Current |