Amoxicillin
- Product NDC
- 57237-028
- 11-digit product format
- 572370028
- Labeler code
- 57237
- Product ID
- 57237-028_679691e2-bbbf-4ed0-a31b-e538b3df75c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA065256
- Marketing category
- ANDA
- Marketing start
- 2005-11-09
- Substance
- AMOXICILLIN
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU |
| Rxcui | 308192, 308194 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57237-028-01 | Amoxicillin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
| 57237-028-20 | Amoxicillin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN TABLET, FILM COATED [CITRON PHARMA LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-028 | AMOXICILLIN TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240809_bb7733f8-6aad-4273-84a0-ef472630203f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57237-028-01 | 57237002801 | 100 TABLET, FILM COATED in 1 BOTTLE (57237-028-01) | 2005-11-09 | 0000-00-00 | No | No | Current |
| 57237-028-20 | 57237002820 | 20 TABLET, FILM COATED in 1 BOTTLE (57237-028-20) | 2005-11-09 | 0000-00-00 | No | No | Current |