CEFIXIME
- Product NDC
- 68180-416
- 11-digit product format
- 681800416
- Labeler code
- 68180
- Product ID
- 68180-416_9f4604c0-f7f8-4e7a-8a19-7a60c416da66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CEFIXIME
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA065129
- Marketing category
- ANDA
- Marketing start
- 2018-12-01
- Marketing end
- 0000-00-00
- Substance
- CEFIXIME
- Active strength
- 400 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 68180-416-08 | 2020-10-27 | C162847 | 48780-1 | 9d75b9d0-9127-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 |
| 68180-416-08 | 2020-10-27 | C162847 | 48780-1 | 9d75b9d0-9127-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 |
| 68180-416-11 | 2020-10-27 | C162847 | 48780-1 | 9d75b9d0-9127-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 |
| 68180-416-11 | 2020-10-27 | C162847 | 48780-1 | 9d75b9d0-9127-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 |
| 68180-416-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9127-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 |
| 68180-416-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9127-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 |
| 68180-416-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9127-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 |
| 68180-416-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9127-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEFIXIME safely and effectively. See full prescribing information for CEFIXIME. CEFIXIME for oral suspension, 100 mg/5 mL CEFIXIME for oral suspension, 200 mg/5 mL CEFIXIME capsules, 400 mg For oral administration Initial U.S. Approval: 1986 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-416-08 | CEFIXIME | 50 in 1 BOTTLE | CAPSULE | 50 | | 14 |
| 68180-416-11 | CEFIXIME | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 14 |
| 68180-416-11 | CEFIXIME | 1 in 1 CARTON | CAPSULE | 1 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CEFIXIME | ACTIVE INGREDIENT | 97I1C92E55 | CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| CEFIXIME ANHYDROUS | ACTIVE MOIETY | XZ7BG04GJX | CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| STRAWBERRY | INACTIVE INGREDIENT | 4J2TY8Y81V | CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | CEFIXIME POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-416 | CEFIXIME POWDER, FOR SUSPENSION CEFIXIME CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 12 | Legacy NDC, 3 package rows | 20250130_6d68dbd9-7d75-4ff1-91db-79ff8ae879ec.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68180-416-08 | 68180041608 | 50 in 1 BOTTLE | Historical |
| 68180-416-11 | 68180041611 | 10 in 1 BLISTER PACK | Historical |