Estradiol and Norethindrone Acetate
- Product NDC
- 50742-658
- 11-digit product format
- 507420658
- Labeler code
- 50742
- Product ID
- 50742-658_e285b638-ef6a-40f1-9fc9-206dac35cb9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol and Norethindrone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA210612
- Marketing category
- ANDA
- Marketing start
- 2019-04-03
- Substance
- ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- .5; .1 mg/1; mg/1
- Pharmacologic classes
- Estradiol Congeners [CS], 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 |
|---|---|---|---|---|---|---|---|
| A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | |
| A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210612-001 | AB |
| A210612-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210612-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2019-04-03 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A210612-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2019-04-03 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210612-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210612-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210612-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210612-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210612-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210612-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210612-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210612-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210612-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210612-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210612-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210612-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210612-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210612-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210612-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210612-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210612-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210612-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210612-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210612-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210612-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210612-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210612-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210612-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210612-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210612-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210612-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210612-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210612-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210612-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210612-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210612-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210612-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210612-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210612-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A210612-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A210612-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210612-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210612-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A210612-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Estradiol and Norethindrone Acetate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESTRADIOL | .5 mg/1 |
| NORETHINDRONE ACETATE | .1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4TI98Z838E | Internal UNII lookup |
| 9S44LIC7OJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 50c786d6-91bd-4eea-9455-ff2abc08372f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50742-658-01 | Estradiol and Norethindrone Acetate | 28 in 1 BLISTER PACK | TABLET | 28 | 4 | |
| 50742-658-28 | Estradiol and Norethindrone Acetate | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 50742-658-68 | Estradiol and Norethindrone Acetate | 6 in 1 CARTON | TABLET | 6 | 4 | |
| 50742-658-84 | Estradiol and Norethindrone Acetate | 3 in 1 CARTON | TABLET | 3 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50742-658-01 | EA - Each | 50742-658 | 2f6c4e6c-d2a6-46a4-97d5-d09955575918 | 1 | 2022-06-06 |
| 50742-658-28 | EA - Each | 50742-658 | 93d2194b-ca6a-4d3d-b24b-dd698877682a | 1 | 2019-08-06 |
| 50742-658-84 | EA - Each | 50742-658 | 9a9615a7-7595-4d2f-a2d7-922efbc34cf3 | 1 | 2019-08-06 |
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 |
|---|---|---|---|---|---|---|
| Estradiol and Norethindrone Acetate | ESTRADIOL AND NORETHINDRONE ACETATE | A-S Medication Solutions | 1521007a-546d-421e-99e1-e10d90c0b090 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 210612 ANDA210612 |
| Estradiol and Norethindrone Acetate | ESTRADIOL AND NORETHINDRONE ACETATE | Ingenus Pharmaceuticals, LLC | 50c786d6-91bd-4eea-9455-ff2abc08372f | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 210612 ANDA210612 50742-658 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1359124 | {28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack | GPCK | 50c786d6-91bd-4eea-9455-ff2abc08372f | 5 |
| 1359127 | {28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } Pack | GPCK | 50c786d6-91bd-4eea-9455-ff2abc08372f | 5 |
| 1359124 | Estra-Noreth Ac 0.5-0.1 MG (28) Oral Tablet 28 Day Pack | PSN | 50c786d6-91bd-4eea-9455-ff2abc08372f | 5 |
| 1359127 | Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day Pack | PSN | 50c786d6-91bd-4eea-9455-ff2abc08372f | 5 |
| 1359123 | estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet | PSN | 50c786d6-91bd-4eea-9455-ff2abc08372f | 5 |
| 1359126 | estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet | PSN | 50c786d6-91bd-4eea-9455-ff2abc08372f | 5 |
| 1359123 | estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet | SCD | 50c786d6-91bd-4eea-9455-ff2abc08372f | 5 |
| 1359126 | estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet | SCD | 50c786d6-91bd-4eea-9455-ff2abc08372f | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50742-658-01 | 50742065801 | 28 in 1 BLISTER PACK | Historical | |||||
| 50742-658-28 | 50742065828 | 1 BLISTER PACK in 1 CARTON (50742-658-28) / 28 TABLET in 1 BLISTER PACK (50742-658-01) | 1 blister pack | 2019-04-03 | 0000-00-00 | No | No | Current |
| 50742-658-68 | 50742065868 | 6 BLISTER PACK in 1 CARTON (50742-658-68) / 28 TABLET in 1 BLISTER PACK (50742-658-01) | 6 blister pack | 2019-04-03 | 0000-00-00 | No | No | Current |
| 50742-658-84 | 50742065884 | 3 BLISTER PACK in 1 CARTON (50742-658-84) / 28 TABLET in 1 BLISTER PACK (50742-658-01) | 3 blister pack | 2019-04-03 | 0000-00-00 | No | No | Current |