ESTRADIOL
- Product NDC
- 24658-702
- 11-digit product format
- 246580702
- Labeler code
- 24658
- Product ID
- 24658-702_8e09c72c-3a37-4b5f-882d-70df65ef558e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESTRADIOL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PURACAP LABORATORIES, LLC
- Application
- ANDA040275
- Marketing category
- ANDA
- Marketing start
- 2021-09-10
- Substance
- ESTRADIOL
- Active strength
- .5 mg/1
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [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 |
|---|---|---|---|---|---|---|---|
| A040275-001 | ESTRADIOL | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | |
| A040275-002 | ESTRADIOL | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | |
| A040275-003 | ESTRADIOL | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040275-001 | AB |
| A040275-002 | AB |
| A040275-003 | 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 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1998-12-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | 1998-12-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040275-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1998-12-29 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040275-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040275-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040275-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040275-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040275-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040275-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040275-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040275-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040275-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040275-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040275-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040275-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040275-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040275-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040275-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040275-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ESTRADIOL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESTRADIOL | .5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4TI98Z838E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 97ace322-341a-4d52-8c63-17265ed9aa8d | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24658-702-01 | ESTRADIOL | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 24658-702-05 | ESTRADIOL | 500 in 1 BOTTLE | TABLET | 500 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24658-702-01 | EA - Each | 24658-702 | d651e95e-05b0-4f10-a02b-79d9797bb279 | 1 | 2021-10-08 |
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 |
|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | 5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | REMEDYREPACK INC. | 477cb52e-8ce2-491f-94a0-869ff60bf7ab | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | afd70875-0a93-40a7-842e-f4359818c2d9 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | REMEDYREPACK INC. | 170ec388-d399-4543-8743-208394b38904 | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | Northwind Health Company, LLC | f76aff99-f415-9045-e053-6294a90afd51 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | Preferred Pharmaceuticals Inc. | 9956a196-fefd-4766-a225-e154fbd3aeff | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | fad3813c-9495-416b-9789-623d5758b4e3 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | cf1ebc1d-8f3c-4468-b565-f0da69986e7c | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | Bryant Ranch Prepack | bfc1beb9-1ade-446e-97dd-55b41c2fa851 | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | 8788ddd1-36a6-416a-b527-75eb41de2808 | 2025-02-18 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | 487ce40e-1f13-4497-994a-c5d91b87b6cc | 2025-02-13 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| Estradiol | ESTRADIOL | Direct_Rx | 032135ee-7bc9-5cdf-e063-6394a90ad9a2 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| Estradiol | ESTRADIOL | Direct_Rx | 01789bad-4be4-ae22-e063-6294a90af392 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | A-S Medication Solutions | 376beb31-5fed-4aae-a16f-71a7d243d5eb | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | PURACAP LABORATORIES, LLC | 97ace322-341a-4d52-8c63-17265ed9aa8d | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 24658-702 |
| ESTRADIOL | ESTRADIOL | EPIC PHARMA, LLC | 9333d92f-2585-4b99-aaea-87c01c95125e | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals, Inc. | 5423c0da-eb10-20cd-e054-00144ff8d46c | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | NuCare Pharmaceuticals,Inc. | 7093dbe4-b096-2ddb-e053-2991aa0a1bb8 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
| ESTRADIOL | ESTRADIOL | Asclemed USA, Inc. | 229b4ec5-d3c8-4406-9fc5-8f633c6447b8 | 2022-10-12 | Boxed warning, Warnings, Adverse reactions | 040275 ANDA040275 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197657 | estradiol 0.5 MG Oral Tablet | PSN | 97ace322-341a-4d52-8c63-17265ed9aa8d | 3 |
| 197658 | estradiol 1 MG Oral Tablet | PSN | 97ace322-341a-4d52-8c63-17265ed9aa8d | 3 |
| 197659 | estradiol 2 MG Oral Tablet | PSN | 97ace322-341a-4d52-8c63-17265ed9aa8d | 3 |
| 197657 | estradiol 0.5 MG Oral Tablet | SCD | 97ace322-341a-4d52-8c63-17265ed9aa8d | 3 |
| 197658 | estradiol 1 MG Oral Tablet | SCD | 97ace322-341a-4d52-8c63-17265ed9aa8d | 3 |
| 197659 | estradiol 2 MG Oral Tablet | SCD | 97ace322-341a-4d52-8c63-17265ed9aa8d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 24658-702-01 | 24658070201 | 100 TABLET in 1 BOTTLE (24658-702-01) | 100 tablet | 2021-09-10 | 0000-00-00 | No | No | Current |
| 24658-702-05 | 24658070205 | 500 TABLET in 1 BOTTLE (24658-702-05) | 500 tablet | 2021-09-10 | 0000-00-00 | No | No | Current |