Clindamycin Phosphate
- Product NDC
- 0168-0277
- 11-digit product format
- 001680277
- Labeler code
- 0168
- Product ID
- 0168-0277_6831719c-6e74-41d9-ab44-225fa088e3a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clindamycin phosphate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Application
- ANDA065139
- Marketing category
- ANDA
- Marketing start
- 2004-12-27
- Substance
- CLINDAMYCIN PHOSPHATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clindamycin Phosphate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLINDAMYCIN PHOSPHATE | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EH6D7113I8 |
| Rxcui | 309337 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0168-0277-40 | Clindamycin Phosphate | 40 g in 1 TUBE, WITH APPLICATOR | CREAM | 40 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLINDAMYCIN PHOSPHATE | ACTIVE INGREDIENT | EH6D7113I8 | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| CLINDAMYCIN | ACTIVE MOIETY | 3U02EL437C | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| CETYL PALMITATE | INACTIVE INGREDIENT | 5ZA2S6B08X | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 5 | |
| CLINDAMYCIN PHOSPHATE | ACTIVE INGREDIENT | EH6D7113I8 | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CLINDAMYCIN | ACTIVE MOIETY | 3U02EL437C | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CETYL PALMITATE | INACTIVE INGREDIENT | 5ZA2S6B08X | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CLINDAMYCIN PHOSPHATE CREAM [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0277 | CLINDAMYCIN PHOSPHATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20220715_997a23c8-f0d7-49d5-af33-e11f2ddab3c7.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 |
|---|
| 0168-0277-40 | 00168027740 | 40 g in 1 TUBE, WITH APPLICATOR (0168-0277-40) | 40 g | 2004-12-27 | 0000-00-00 | No | No | Current |