Clarithromycin
- Product NDC
- 0781-6023
- 11-digit product format
- 007816023
- Labeler code
- 0781
- Product ID
- 0781-6023_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA065283
- Marketing category
- ANDA
- Marketing start
- 2007-09-04
- Substance
- CLARITHROMYCIN
- Active strength
- 250 mg/5mL
- Pharmacologic classes
- Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clarithromycin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLARITHROMYCIN | 250 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H1250JIK0A |
| Rxcui | 240741, 309322 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-6023-46 | Clarithromycin | 100 mL in 1 BOTTLE | FOR SUSPENSION | 100 | | 15 |
| 0781-6023-52 | Clarithromycin | 50 mL in 1 BOTTLE | FOR SUSPENSION | 50 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLARITHROMYCIN | ACTIVE INGREDIENT | H1250JIK0A | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| CLARITHROMYCIN | ACTIVE MOIETY | H1250JIK0A | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 9 | |
| CLARITHROMYCIN | ACTIVE INGREDIENT | H1250JIK0A | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| CLARITHROMYCIN | ACTIVE MOIETY | H1250JIK0A | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | CLARITHROMYCIN FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-6023 | CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC] | 15 | Current NDC, Legacy NDC, 2 package rows | 20231102_22457862-0f88-4be8-b507-1c8f264269f2.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 |
|---|
| 0781-6023-46 | 00781602346 | 100 mL in 1 BOTTLE (0781-6023-46) | 100 ml | 2007-09-04 | 0000-00-00 | No | No | Current |
| 0781-6023-52 | 00781602352 | 50 mL in 1 BOTTLE (0781-6023-52) | 50 ml | 2007-09-04 | 0000-00-00 | No | No | Current |