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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202770-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A202770-001 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 0.03MG;1.5MG | TABLET / ORAL-21 | AB | 2015-02-19 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202770-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202770-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202770-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202770-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202770-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202770-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202770-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202770-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202770-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202770-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202770-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202770-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202770-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202770-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202770-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202770-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202770-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202770-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202770-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202770-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202770-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202770-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202770-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A202770-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A202770-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A202770-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A202770-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202770-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A202770-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202770-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A202770-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A202770-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202770-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202770-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202770-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202770-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A202770-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A202770-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202770-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A202770-001 | AB | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LUIZZA 1.5/30
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ETHINYL ESTRADIOL | 30 ug/1 |
| NORETHINDRONE ACETATE | 1.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 423D2T571U | Internal UNII lookup |
| 9S44LIC7OJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b1c3e33d-ec95-cd89-7ad9-36994c802a1f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70700-314-78 | EA - Each | 70700-314 | d76e22bf-b98f-4254-94e4-4a633ffbe060 | 1 | 2025-10-14 |
| 70700-314-79 | EA - Each | 70700-314 | b33ce6cb-7da1-4335-a79c-4c4de8e27555 | 1 | 2025-10-14 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LUIZZA 1.5/30 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Xiromed LLC | b1c3e33d-ec95-cd89-7ad9-36994c802a1f | 2025-02-12 | Warnings, Adverse reactions | 202770 ANDA202770 70700-314 |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Mylan Pharmaceuticals Inc. | 3108a9bc-3378-459d-8f6b-bd5eff2ad657 | 2024-01-15 | Boxed warning, Warnings, Adverse reactions | 202770 ANDA202770 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2712092 | {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } Pack [Luizza 1.5/30 21 Day] | BPCK | b1c3e33d-ec95-cd89-7ad9-36994c802a1f | 1 |
| 1359028 | {21 (ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet) } Pack | GPCK | b1c3e33d-ec95-cd89-7ad9-36994c802a1f | 1 |
| 1359028 | Eth estra-Noreth Ac 0.03-1.5 MG (21) Oral Tablet 21 Day Pack | PSN | b1c3e33d-ec95-cd89-7ad9-36994c802a1f | 1 |
| 2712092 | Luizza 1.5/30 21 Day Pack | PSN | b1c3e33d-ec95-cd89-7ad9-36994c802a1f | 1 |
| 1359022 | norethindrone acetate 1.5 MG / ethinyl estradiol 30 MCG Oral Tablet | PSN | b1c3e33d-ec95-cd89-7ad9-36994c802a1f | 1 |
| 1359022 | ethinyl estradiol 0.03 MG / norethindrone acetate 1.5 MG Oral Tablet | SCD | b1c3e33d-ec95-cd89-7ad9-36994c802a1f | 1 |
| 1359022 | ethinyl estradiol 30 MCG / norethindrone acetate 1.5 MG Oral Tablet | SY | b1c3e33d-ec95-cd89-7ad9-36994c802a1f | 1 |
| 2712092 | Luizza 1.5/30 21 Day Pack | SY | b1c3e33d-ec95-cd89-7ad9-36994c802a1f | 1 |
Packages#
| 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 |