AMOXICILLIN
- Product NDC
- 61919-355
- 11-digit product format
- 619190355
- Labeler code
- 61919
- Product ID
- 61919-355_9c5941d2-59e6-a016-e053-2a95a90a4fea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMOXICILLIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA064076
- Marketing category
- ANDA
- Marketing start
- 2016-06-15
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 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 |
|---|---|---|---|---|---|
| 61919-355-20 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ee22-a426-e053-dadaa90af4c2 | AMOXICILLIN |
| 61919-355-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4bb8-f424-e053-dadaa90a57ce | AMOXICILLIN 500mg 30 TABS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-355-20 | AMOXICILLIN | 20 in 1 BOTTLE | CAPSULE | 20 | 2 | |
| 61919-355-30 | AMOXICILLIN | 30 in 1 BOTTLE | CAPSULE | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-355-20 | EA - Each | 61919-355 | a0b7f717-bf2e-4730-8d4e-2302f46c0fa2 | 1 | 2018-03-08 |
| 61919-355-30 | EA - Each | 61919-355 | e2c97253-47ab-4816-8d41-a831f51a7941 | 1 | 2016-09-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-355 | AMOXICILLIN CAPSULE [DIRECT RX] | 2 | Legacy NDC, 1 package rows | 20200128_35651b85-b735-7299-e054-00144ff8d46c.zip |
| 61919-355 | AMOXICILLIN CAPSULE [DIRECTRX] | 1 | Legacy NDC, 1 package rows | 20160414_30635424-e6bc-1bff-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308191 | amoxicillin 500 MG Oral Capsule | PSN | 35651b85-b735-7299-e054-00144ff8d46c | 2 |
| 308191 | amoxicillin 500 MG Oral Capsule | SCD | 35651b85-b735-7299-e054-00144ff8d46c | 2 |
| 308191 | amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule | SY | 35651b85-b735-7299-e054-00144ff8d46c | 2 |
| 308191 | amoxicillin 500 MG Oral Capsule | PSN | 30635424-e6bc-1bff-e054-00144ff88e88 | 1 |
| 308191 | amoxicillin 500 MG Oral Capsule | SCD | 30635424-e6bc-1bff-e054-00144ff88e88 | 1 |
| 308191 | amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule | SY | 30635424-e6bc-1bff-e054-00144ff88e88 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-355-20 | 61919035520 | 20 CAPSULE in 1 BOTTLE (61919-355-20) | 20 capsule | 2016-06-15 | 0000-00-00 | No | No | Current |
| 61919-355-30 | 61919035530 | 30 in 1 BOTTLE | Historical |