Amoxicillin
- Product NDC
- 10544-950
- 11-digit product format
- 105440950
- Labeler code
- 10544
- Product ID
- 10544-950_31a57dee-71d7-1b8f-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA065256
- Marketing category
- ANDA
- Marketing start
- 2015-10-07
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 875 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 10544-950-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4b4c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use amoxicillin tablets safely and effectively. See full prescribing information for amoxicillin tablets, USP. Amoxicillin Tablets, USP Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, USP and other antibacterial drugs, amoxicillin tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. |
| 10544-950-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4b4c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use amoxicillin tablets safely and effectively. See full prescribing information for amoxicillin tablets, USP. Amoxicillin Tablets, USP Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, USP and other antibacterial drugs, amoxicillin tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-950-06 | Amoxicillin | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 2 |
| 10544-950-20 | Amoxicillin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-950 | AMOXICILLIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 2 | Legacy NDC, 2 package rows | 20160430_2183bef9-f79d-54f7-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-950-06 | 10544095006 | 6 in 1 BOTTLE | Historical |
| 10544-950-20 | 10544095020 | 20 in 1 BOTTLE | Historical |