Amoxicillin
- Product NDC
- 10544-959
- 11-digit product format
- 105440959
- Labeler code
- 10544
- Product ID
- 10544-959_32949847-4166-404f-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc
- Application
- ANDA064076
- Marketing category
- ANDA
- Marketing start
- 2016-03-16
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 250 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 502415e5-4ac7-4266-a01a-ef44aa3c028d | Product name | 7 | 20250623 |
| d0f377c9-74d8-e2e3-e06e-4d37534f5c0f | Product name | 3 | 20250620 |
| 2ebbc361-d28f-48a9-a286-c1ae09cdaf5c | Product name | 3 | 20230314 |
| 2bb254ff-3d7f-4bdb-abf9-476506008c55 | Product name | 1 | 20230117 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10544-959-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1c32-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN Capsules and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules and for Oral Suspension, USP. AMOXICILLIN Capsules and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-959-30 | Amoxicillin | 30 in 1 BOTTLE | CAPSULE | 30 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | 7f813093-98a2-452a-b6f1-132fe40f76c7 | 4 |
| 308191 | amoxicillin 500 MG Oral Capsule | PSN | 7f813093-98a2-452a-b6f1-132fe40f76c7 | 4 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | 7f813093-98a2-452a-b6f1-132fe40f76c7 | 4 |
| 308191 | amoxicillin 500 MG Oral Capsule | SCD | 7f813093-98a2-452a-b6f1-132fe40f76c7 | 4 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | 7f813093-98a2-452a-b6f1-132fe40f76c7 | 4 |
| 308191 | amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule | SY | 7f813093-98a2-452a-b6f1-132fe40f76c7 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10544-959-30 | 10544095930 | 30 in 1 BOTTLE | Historical |