Amoxicillin
- Product NDC
- 42582-213
- 11-digit product format
- 425820213
- Labeler code
- 42582
- Product ID
- 42582-213_a4168d48-e412-463e-b25c-c6c99224d1bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bi-Coastal Pharma International LLC
- Application
- ANDA062058
- Marketing category
- ANDA
- Marketing start
- 2016-02-01
- 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 |
|---|---|---|---|---|---|
| 42582-213-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2685-f424-e053-dadaa90a57ce | Amoxicillin Capsules, USP 250 mg and 500 mg |
| 42582-213-18 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2685-f424-e053-dadaa90a57ce | Amoxicillin Capsules, USP 250 mg and 500 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42582-213-10 | Amoxicillin | 100 in 1 BOTTLE | CAPSULE | 100 | 2 | |
| 42582-213-18 | Amoxicillin | 500 in 1 BOTTLE | CAPSULE | 500 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42582-213-10 | EA - Each | 42582-213 | 875db22d-82f8-4a66-9e09-0a3304d2b716 | 1 | 2016-09-02 |
| 42582-213-18 | EA - Each | 42582-213 | 697f22a9-0b02-428d-9e61-b1e0ca2a26e0 | 1 | 2016-09-02 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308182 | amoxicillin 250 MG Oral Capsule | PSN | 5dd36bf2-8521-4da1-baa0-0eae24b2a3ce | 2 |
| 308191 | amoxicillin 500 MG Oral Capsule | PSN | 5dd36bf2-8521-4da1-baa0-0eae24b2a3ce | 2 |
| 308182 | amoxicillin 250 MG Oral Capsule | SCD | 5dd36bf2-8521-4da1-baa0-0eae24b2a3ce | 2 |
| 308191 | amoxicillin 500 MG Oral Capsule | SCD | 5dd36bf2-8521-4da1-baa0-0eae24b2a3ce | 2 |
| 308182 | amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule | SY | 5dd36bf2-8521-4da1-baa0-0eae24b2a3ce | 2 |
| 308191 | amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule | SY | 5dd36bf2-8521-4da1-baa0-0eae24b2a3ce | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 42582-213-10 | 42582021310 | 100 in 1 BOTTLE | Historical |
| 42582-213-18 | 42582021318 | 500 in 1 BOTTLE | Historical |