Atovaquone and Proguanil Hydrochloride
- Product NDC
- 50090-1302
- 11-digit product format
- 500901302
- Labeler code
- 50090
- Product ID
- 50090-1302_0f4d7baa-42e4-4375-ab9b-97f96eebb3fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atovaquone and Proguanil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA091211
- Marketing category
- ANDA
- Marketing start
- 2011-09-15
- Substance
- ATOVAQUONE; PROGUANIL HYDROCHLORIDE
- Active strength
- 250; 100 mg/1; mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 50090-1302 | 50090-1302-7 | D | Discontinued by firm | 2026-10-16 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-1302-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-1302-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-1302-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-1302-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-1302-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-1302-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-1302-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-1302-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-1302-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-1302-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-1302-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-1302-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-1302-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-1302-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-1302-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-1302-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-1302-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-1302-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-1302-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-1302-7 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | |
| A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091211-001 | AB |
| A091211-002 | 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 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091211-001 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 250MG;100MG | TABLET / ORAL | AB | 2011-01-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091211-002 | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET / ORAL | AB | 2015-04-06 | 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 | A091211-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091211-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091211-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091211-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091211-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091211-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091211-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091211-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091211-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A091211-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091211-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A091211-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091211-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A091211-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091211-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A091211-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091211-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A091211-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091211-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A091211-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091211-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091211-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A091211-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A091211-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A091211-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A091211-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091211-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091211-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091211-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091211-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091211-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091211-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091211-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091211-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A091211-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A091211-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A091211-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A091211-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091211-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091211-002 | 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
- Atovaquone and Proguanil Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ATOVAQUONE | 250 mg/1 |
| PROGUANIL HYDROCHLORIDE | 100 mg/1 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-1302-0 | EA - Each | 50090-1302 | 7ad09f1b-fb70-4d9c-9f21-277668805a66 | 1 | 2018-11-06 |
| 50090-1302-1 | EA - Each | 50090-1302 | 543e5732-13f0-4f07-9f56-faaea6156d24 | 1 | 2018-11-06 |
| 50090-1302-2 | EA - Each | 50090-1302 | c692be7e-5da9-4784-ae43-acc47b3870eb | 1 | 2018-11-06 |
| 50090-1302-3 | EA - Each | 50090-1302 | 3173a86c-b4e4-4f6c-a589-b6bd0c55b7a6 | 1 | 2018-11-06 |
| 50090-1302-4 | EA - Each | 50090-1302 | 7f6535f0-5e5f-4809-a5a0-5caa2c78337f | 1 | 2018-11-06 |
| 50090-1302-5 | EA - Each | 50090-1302 | fa3f2b94-ea9d-4c91-a435-a54ce5f949e5 | 1 | 2018-11-06 |
| 50090-1302-6 | EA - Each | 50090-1302 | 72d9cbcf-0411-4fe0-897d-084ace46654f | 1 | 2018-11-06 |
| 50090-1302-7 | EA - Each | 50090-1302 | 6f1c8d2a-0ea6-45ca-9c87-69f6e35e13c1 | 1 | 2018-11-06 |
| 50090-1302-8 | EA - Each | 50090-1302 | 85a7f6de-3f39-4e18-b944-a83c13554b63 | 1 | 2018-11-06 |
| 50090-1302-9 | EA - Each | 50090-1302 | e093c698-f3b0-4978-93a1-b6f7e5ea6c2f | 1 | 2018-11-06 |
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 |
|---|---|---|---|---|---|---|
| Atovaquone and Proguanil Hydrochloride | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | BluePoint Laboratories | ad25ab65-42aa-48f6-b5ed-247f3685d5bf | 2026-09-03 | Warnings, Adverse reactions | 091211 ANDA091211 |
| Atovaquone and Proguanil Hydrochloride | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | Bryant Ranch Prepack | e4ff57f7-07af-4872-ac3a-c521e098ccfe | 2026-07-27 | Warnings, Adverse reactions | 091211 ANDA091211 |
| Atovaquone and Proguanil Hydrochloride Pediatric | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC | Glenmark Pharmaceuticals Inc.,USA | 4b80d087-eaa7-448f-967e-344de7f16436 | 2026-04-24 | Warnings, Adverse reactions | 091211 ANDA091211 |
| Atovaquone and Proguanil Hydrochloride | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE | Proficient Rx LP | e74b00fc-8743-4e9d-8a83-aab8e531b3ba | 2024-07-01 | Warnings, Adverse reactions | 091211 ANDA091211 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-1302-0 | 50090130200 | 7 TABLET, FILM COATED in 1 BOTTLE (50090-1302-0) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-1302-1 | 50090130201 | 12 TABLET, FILM COATED in 1 BOTTLE (50090-1302-1) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-1302-2 | 50090130202 | 14 TABLET, FILM COATED in 1 BOTTLE (50090-1302-2) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-1302-3 | 50090130203 | 16 TABLET, FILM COATED in 1 BOTTLE (50090-1302-3) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-1302-4 | 50090130204 | 24 TABLET, FILM COATED in 1 BOTTLE (50090-1302-4) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-1302-5 | 50090130205 | 5 TABLET, FILM COATED in 1 BOTTLE (50090-1302-5) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-1302-6 | 50090130206 | 10 TABLET, FILM COATED in 1 BOTTLE (50090-1302-6) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-1302-7 | 50090130207 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-1302-7) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-1302-8 | 50090130208 | 20 TABLET, FILM COATED in 1 BOTTLE (50090-1302-8) | 2017-09-29 | 0000-00-00 | No | No | Current |
| 50090-1302-9 | 50090130209 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-1302-9) | 2017-09-28 | 0000-00-00 | No | No | Current |