cephalexin
- Product NDC
- 68180-440
- 11-digit product format
- 681800440
- Labeler code
- 68180
- Product ID
- 68180-440_78aee1aa-f859-489e-98b5-78af55b92374
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cephalexin
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA065234
- Marketing category
- ANDA
- Marketing start
- 2017-08-21
- Substance
- CEPHALEXIN
- Active strength
- 125 mg/5mL
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- cephalexin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CEPHALEXIN | 125 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OBN7UDS42Y |
| Rxcui | 309110, 309113 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-440-01 | cephalexin | 100 mL in 1 BOTTLE | FOR SUSPENSION | 100 | | 13 |
| 68180-440-02 | cephalexin | 200 mL in 1 BOTTLE | FOR SUSPENSION | 200 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CEPHALEXIN | ACTIVE INGREDIENT | OBN7UDS42Y | CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| CEPHALEXIN ANHYDROUS | ACTIVE MOIETY | 5SFF1W6677 | CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| STRAWBERRY | INACTIVE INGREDIENT | 4J2TY8Y81V | CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-440 | CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240817_25ef498a-7a7e-4543-a544-b9d0e99f9cd9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-440-01 | 68180044001 | 100 mL in 1 BOTTLE (68180-440-01) | 100 ml | 2017-08-21 | 0000-00-00 | No | No | Current |
| 68180-440-02 | 68180044002 | 200 mL in 1 BOTTLE (68180-440-02) | 200 ml | 2017-09-06 | 0000-00-00 | No | No | Current |