Amoxicillin
- Product NDC
- 43063-574
- 11-digit product format
- 430630574
- Labeler code
- 43063
- Product ID
- 43063-574_32fbc384-f6a4-23ce-e063-6394a90af1e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA065271
- Marketing category
- ANDA
- Marketing start
- 2005-11-09
- Substance
- AMOXICILLIN
- Active strength
- 250 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMOXICILLIN | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU |
| Rxcui | 308182 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-574-04 | Amoxicillin | 4 in 1 BOTTLE, PLASTIC | CAPSULE | 4 | | 23 |
| 43063-574-06 | Amoxicillin | 6 in 1 BOTTLE, PLASTIC | CAPSULE | 6 | | 23 |
| 43063-574-15 | Amoxicillin | 15 in 1 BOTTLE, PLASTIC | CAPSULE | 15 | | 23 |
| 43063-574-21 | Amoxicillin | 21 in 1 BOTTLE, PLASTIC | CAPSULE | 21 | | 23 |
| 43063-574-30 | Amoxicillin | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-574 | AMOXICILLIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 23 | Current NDC, Legacy NDC, 5 package rows | 20250418_d37f2e3c-01f0-4a81-a46f-1615b82e2499.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-574-04 | 43063057404 | 4 CAPSULE in 1 BOTTLE, PLASTIC (43063-574-04) | 4 capsule | 2016-07-12 | 0000-00-00 | No | No | Current |
| 43063-574-06 | 43063057406 | 6 CAPSULE in 1 BOTTLE, PLASTIC (43063-574-06) | 6 capsule | 2015-06-02 | 0000-00-00 | No | No | Current |
| 43063-574-15 | 43063057415 | 15 CAPSULE in 1 BOTTLE, PLASTIC (43063-574-15) | 15 capsule | 2015-08-06 | 0000-00-00 | No | No | Current |
| 43063-574-21 | 43063057421 | 21 CAPSULE in 1 BOTTLE, PLASTIC (43063-574-21) | 21 capsule | 2015-10-06 | 0000-00-00 | No | No | Current |
| 43063-574-30 | 43063057430 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-574-30) | 30 capsule | 2015-05-12 | 0000-00-00 | No | No | Current |