donepezil hydrochloride
- Product NDC
- 43547-276
- 11-digit product format
- 435470276
- Labeler code
- 43547
- Product ID
- 43547-276_dcfd9a94-e1bc-4b53-ae6f-0200ee714917
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- donepezil hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA200292
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- Substance
- DONEPEZIL HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
- 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 |
|---|---|---|---|---|---|---|---|
| A200292-001 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | |
| A200292-002 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200292-001 | AB |
| A200292-002 | 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 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A200292-001 | DONEPEZIL HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2011-05-31 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A200292-002 | DONEPEZIL HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2011-05-31 | 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 | A200292-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200292-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200292-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200292-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200292-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200292-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200292-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200292-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200292-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200292-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200292-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200292-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200292-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200292-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200292-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200292-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200292-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200292-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200292-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200292-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200292-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200292-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200292-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200292-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200292-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200292-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A200292-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A200292-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200292-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200292-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A200292-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A200292-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A200292-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A200292-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A200292-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A200292-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A200292-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A200292-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A200292-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A200292-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- donepezil hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DONEPEZIL HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3O2T2PJ89D | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 042a59ea-131a-4806-b0f4-2f791d4414e2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 94db636e-a074-45fd-8e8d-331920a99436 | Product name | 4 | 20250103 |
| bc94e09e-ba00-42fe-bb88-b0b948d7b8f7 | Product name | 1 | 20221214 |
| d7e50b51-94ef-29ef-8273-837d555048c1 | Product name | 9 | 20160811 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43547-276-03 | donepezil hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 15 | |
| 43547-276-09 | donepezil hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | 15 | |
| 43547-276-11 | donepezil hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-276-03 | EA - Each | 43547-276 | 4cd6a53e-1d20-4293-84cc-0633404beed4 | 1 | 2012-07-24 |
| 43547-276-09 | EA - Each | 43547-276 | c11c81fa-1608-495d-ae73-12d48397a938 | 1 | 2012-07-24 |
| 43547-276-11 | EA - Each | 43547-276 | e6e28b51-902f-4196-9666-50604a7671e3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| donepezil hydrochloride | DONEPEZIL HYDROCHLORIDE | REMEDYREPACK INC. | 41c095b6-acd9-4627-a813-bbca7ecafee5 | 2026-03-30 | Warnings, Adverse reactions | 200292 ANDA200292 |
| donepezil hydrochloride | DONEPEZIL HYDROCHLORIDE | Solco Healthcare US, LLC | 48178cb4-4fee-47c0-88e9-a4f017f1f448 | 2025-06-30 | Warnings, Adverse reactions | 200292 ANDA200292 |
| donepezil hydrochloride | DONEPEZIL HYDROCHLORIDE | Solco Healthcare US, LLC | 042a59ea-131a-4806-b0f4-2f791d4414e2 | 2025-06-30 | Warnings, Adverse reactions | 200292 ANDA200292 43547-276 |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | Direct_Rx | 93dddf28-094b-dd8c-e053-2995a90a63e9 | 2025-01-22 | Warnings, Adverse reactions | 200292 ANDA200292 |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | DirectRx | cb1b3ed1-6e68-08e2-e053-2995a90a68c4 | 2025-01-20 | Warnings, Adverse reactions | 200292 ANDA200292 |
| donepezil hydrochloride | DONEPEZIL HYDROCHLORIDE | Bryant Ranch Prepack | c26d9bf3-e148-48bb-8f4f-e8c73804b311 | 2023-11-17 | Warnings, Adverse reactions | 200292 ANDA200292 |
| donepezil hydrochloride | DONEPEZIL HYDROCHLORIDE | A-S Medication Solutions | 5d46ef3c-0dee-4389-a2d5-997ea8342817 | 2023-02-06 | Warnings, Adverse reactions | 200292 ANDA200292 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 997223 | donepezil HCl 10 MG Oral Tablet | PSN | 042a59ea-131a-4806-b0f4-2f791d4414e2 | 15 |
| 997223 | donepezil HCl 10 MG Oral Tablet | PSN | 41c095b6-acd9-4627-a813-bbca7ecafee5 | 15 |
| 997229 | donepezil HCl 5 MG Oral Tablet | PSN | 042a59ea-131a-4806-b0f4-2f791d4414e2 | 15 |
| 997223 | donepezil hydrochloride 10 MG Oral Tablet | SCD | 042a59ea-131a-4806-b0f4-2f791d4414e2 | 15 |
| 997223 | donepezil hydrochloride 10 MG Oral Tablet | SCD | 41c095b6-acd9-4627-a813-bbca7ecafee5 | 15 |
| 997229 | donepezil hydrochloride 5 MG Oral Tablet | SCD | 042a59ea-131a-4806-b0f4-2f791d4414e2 | 15 |
| 997223 | donepezil HCl 10 MG Oral Tablet | PSN | c26d9bf3-e148-48bb-8f4f-e8c73804b311 | 6 |
| 997223 | donepezil hydrochloride 10 MG Oral Tablet | SCD | c26d9bf3-e148-48bb-8f4f-e8c73804b311 | 6 |
| 997223 | donepezil HCl 10 MG Oral Tablet | PSN | 598bd4d0-18bc-2542-e053-2991aa0a0762 | 2 |
| 997223 | donepezil HCl 10 MG Oral Tablet | PSN | cb1b3ed1-6e68-08e2-e053-2995a90a68c4 | 2 |
| 997223 | donepezil hydrochloride 10 MG Oral Tablet | SCD | 598bd4d0-18bc-2542-e053-2991aa0a0762 | 2 |
| 997223 | donepezil hydrochloride 10 MG Oral Tablet | SCD | cb1b3ed1-6e68-08e2-e053-2995a90a68c4 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43547-276-03 | 43547027603 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-276-03) | 2011-11-01 | 0000-00-00 | No | No | Current |
| 43547-276-09 | 43547027609 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-276-09) | 2011-11-01 | 0000-00-00 | No | No | Current |
| 43547-276-11 | 43547027611 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-276-11) | 2011-11-01 | 0000-00-00 | No | No | Current |