ABIGALE
- Product NDC
- 70700-330
- 11-digit product format
- 707000330
- Labeler code
- 70700
- Product ID
- 70700-330_35d8f763-8f98-f5ea-fae8-1367b638e82c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol and norethindrone acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Xiromed LLC
- Application
- ANDA207261
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- Substance
- ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 1; .5 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 |
|---|---|---|---|---|---|---|---|
| A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | |
| A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207261-001 | AB |
| A207261-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207261-001 | ESTRADIOL AND NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET / ORAL | AB | 2017-02-10 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207261-002 | ESTRADIOL AND NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET / ORAL | AB | 2017-02-10 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A207261-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207261-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207261-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A207261-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A207261-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A207261-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207261-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207261-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A207261-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A207261-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A207261-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A207261-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A207261-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207261-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A207261-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207261-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207261-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207261-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A207261-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207261-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207261-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207261-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A207261-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A207261-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A207261-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A207261-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207261-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207261-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207261-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207261-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207261-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207261-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207261-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207261-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A207261-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A207261-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A207261-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A207261-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207261-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207261-002 | AB | 1 | 3a93d1ddd44b… |
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
- ABIGALE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESTRADIOL | 1 mg/1 |
| NORETHINDRONE ACETATE | .5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9S44LIC7OJ | Internal UNII lookup |
| 4TI98Z838E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| df013d36-de10-0607-7e12-95ed43bf7ee9 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70700-330-84 | ABIGALE | 28 in 1 BLISTER PACK | TABLET | 28 | 1 | |
| 70700-330-84 | ABIGALE | 1 in 1 POUCH | TABLET | 1 | 1 | |
| 70700-330-85 | ABIGALE | 3 in 1 CARTON | TABLET | 3 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70700-330-84 | EA - Each | 70700-330 | 0c69decd-b362-4d0e-9134-9bebee7a7c51 | 1 | 2025-07-08 |
| 70700-330-85 | EA - Each | 70700-330 | 6903630e-e2e4-4818-bbef-b8a13c4a77e1 | 1 | 2025-07-08 |
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 |
|---|---|---|---|---|---|---|
| ABIGALE LO | ESTRADIOL AND NORETHINDRONE ACETATE | Xiromed LLC | df013d36-de10-0607-7e12-95ed43bf7ee9 | 2024-09-17 | Boxed warning, Warnings, Adverse reactions | 207261 ANDA207261 70700-330 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2706647 | {28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack [Abigale Lo 0.5/0.1 28 Day] | BPCK | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 2706646 | {28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } Pack [Abigale 1/0.5 28 Day] | BPCK | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 1359124 | {28 (estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet) } Pack | GPCK | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 1359127 | {28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } Pack | GPCK | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 2706646 | Abigale 1/0.5 28 Day Pack | PSN | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 2706647 | Abigale Lo 0.5/0.1 28 Day Pack | PSN | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 1359124 | Estra-Noreth Ac 0.5-0.1 MG (28) Oral Tablet 28 Day Pack | PSN | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 1359127 | Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day Pack | PSN | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 1359123 | estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet | PSN | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 1359126 | estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet | PSN | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 1359123 | estradiol 0.5 MG / norethindrone acetate 0.1 MG Oral Tablet | SCD | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 1359126 | estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet | SCD | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 2706646 | Abigale 1/0.5 28 Day Pack | SY | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
| 2706647 | Abigale Lo 0.5/0.1 28 Day Pack | SY | df013d36-de10-0607-7e12-95ed43bf7ee9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70700-330-84 | 70700033084 | 28 in 1 BLISTER PACK | Historical | ||||
| 70700-330-85 | 70700033085 | 3 POUCH in 1 CARTON (70700-330-85) / 1 BLISTER PACK in 1 POUCH (70700-330-84) / 28 TABLET in 1 BLISTER PACK | 3 pouch | 2025-01-29 | No | No | Current |