Amoxicillin
- Product NDC
- 64205-104
- 11-digit product format
- 642050104
- Labeler code
- 64205
- Product ID
- 64205-104_4689d485-ecc3-4c14-ba94-2eb84459ca0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ReadyMeds
- Application
- ANDA062058
- Marketing category
- ANDA
- Marketing start
- 2012-01-12
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 500 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 |
|---|---|---|---|---|---|
| 64205-104-30 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4b18-60a7-e053-dbdaa90a05bd | PRESCRIBING INFORMATION Amoxicillin Capsules, USP 250 mg and 500 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64205-104-30 | Amoxicillin | 30 in 1 BOTTLE | CAPSULE | 30 | 3 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN CAPSULE [READYMEDS] | 3 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN CAPSULE [READYMEDS] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | AMOXICILLIN CAPSULE [READYMEDS] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | AMOXICILLIN CAPSULE [READYMEDS] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | AMOXICILLIN CAPSULE [READYMEDS] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN CAPSULE [READYMEDS] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AMOXICILLIN CAPSULE [READYMEDS] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN CAPSULE [READYMEDS] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308191 | amoxicillin 500 MG Oral Capsule | PSN | e2df55ed-d926-4414-a4a2-4f3982d20c21 | 3 |
| 308191 | amoxicillin 500 MG Oral Capsule | SCD | e2df55ed-d926-4414-a4a2-4f3982d20c21 | 3 |
| 308191 | amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule | SY | e2df55ed-d926-4414-a4a2-4f3982d20c21 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64205-104-30 | 64205010430 | 30 in 1 BOTTLE | Historical |