Estradiol
- Product NDC
- 63629-6467
- 11-digit product format
- 636296467
- Labeler code
- 63629
- Product ID
- 63629-6467_5432a59b-dc55-4713-80af-aad95f866477
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040197
- Marketing category
- ANDA
- Marketing start
- 1997-10-28
- Marketing end
- 0000-00-00
- Substance
- ESTRADIOL
- Active strength
- 1 mg/1
- Pharmacologic classes
- Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63629-6467 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 63629-6467 | 63629-6467-1 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-6467-1 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 63629-6467-1 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040197-001 | ESTRADIOL | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | |
| A040197-002 | ESTRADIOL | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | |
| A040197-003 | ESTRADIOL | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040197-001 | AB |
| A040197-002 | AB |
| A040197-003 | 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 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-002 | ESTRADIOL | 1MG | TABLET / ORAL | AB | 1997-10-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-003 | ESTRADIOL | 2MG | TABLET / ORAL | AB | RS | 1997-10-22 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040197-001 | ESTRADIOL | 0.5MG | TABLET / ORAL | AB | 1997-10-22 | 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 | A040197-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040197-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040197-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040197-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040197-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040197-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040197-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040197-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040197-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040197-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040197-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040197-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040197-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040197-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040197-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040197-001 | AB | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63629-6467-1 | 2020-08-31 | C162847 | 48780-1 | 9d75b9d1-0f1e-f424-e053-dadaa90a57ce | Estradiol Tablets, USP |
| 63629-6467-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0f1e-f424-e053-dadaa90a57ce | Estradiol Tablets, USP |
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 | REMEDYREPACK INC. | 774ee81b-8e29-46af-ab12-7157f63b443b | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Northwind Health Company, LLC | f6caf47a-1917-c493-e053-6394a90af63e | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Northwind Health Company, LLC | f6cb38ab-fdff-9c07-e053-6294a90ad59a | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | f3a77482-f490-f350-e053-2a95a90ad8cb | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | c8ac2e13-58d5-4e70-e053-2995a90aff04 | 2025-09-22 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | American Health Packaging | 265a1ee1-f314-4324-a2e1-0120a9a00a20 | 2025-05-02 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 3e84e3e7-4b50-407f-a215-45363b541384 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | PD-Rx Pharmaceuticals, Inc. | d0d1c2c8-b175-4250-9343-d7db65b72e8f | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | NuCare Pharmaceuticals,Inc. | dd7d2d2a-e76b-7dfe-e053-2995a90a790a | 2025-02-26 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | PharmPak, Inc. | 20b50139-4e13-4f0c-aaf5-ecb83911d9e6 | 2025-01-16 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Proficient Rx LP | 7e570b07-2a9e-49bf-b224-1e34f6eda3ab | 2024-10-01 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | A-S Medication Solutions | 7f3c96ce-c855-4372-95ba-7759dd82bcca | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 80d6644a-d6f2-48e7-a685-92c4255b19fe | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 414b846a-d6d9-4e8a-9632-12e296fc13c3 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | Teva Pharmaceuticals USA, Inc. | c4936878-1643-4e7f-9b0d-e4957935aef2 | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
| Estradiol | ESTRADIOL | PharmPak, Inc. | 8f8c5a0b-4d7b-a5cb-e053-2995a90a494e | 2022-10-09 | Boxed warning, Warnings, Adverse reactions | 040197 ANDA040197 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-6467-1 | 63629646701 | 30 TABLET in 1 BOTTLE (63629-6467-1) | 30 tablet | 2015-09-04 | 0000-00-00 | No | No | Current |