LUIZZA 1/20
- Product NDC
- 70700-313
- 11-digit product format
- 707000313
- Labeler code
- 70700
- Product ID
- 70700-313_3624fac4-47aa-b3c7-e063-6394a90ae96c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone acetate and ethinyl estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Xiromed, LLC
- Application
- ANDA202771
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- .02; 1 mg/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 1/20
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | .02 mg/1 |
| NORETHINDRONE ACETATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1358762, 1358776, 2714657 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70700-313-79 | LUIZZA 1/20 | 1 in 1 POUCH | TABLET | 1 | | 1 |
| 70700-313-79 | LUIZZA 1/20 | 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 |
|---|
| 70700-313 | LUIZZA 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [XIROMED, LLC] | 1 | Current NDC, 2 package rows | 20250529_88d90f33-1034-4d27-034f-11d9c441c9e7.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 |
|---|
| 70700-313-79 | 70700031379 | 3 POUCH in 1 CARTON (70700-313-79) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK | 3 pouch | 2025-01-29 | No | No | Current |