Home NDC 0168-0277 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065139-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065139-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065139-001 CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM / VAGINAL AB 2004-12-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH6D7113I8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309337 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 [PREFERRED PHARMACEUTICALS, INC.] 2 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 CETYL PALMITATE INACTIVE INGREDIENT 5ZA2S6B08X CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP CLINDAMYCIN PHOSPHATE CREAM [PREFERRED PHARMACEUTICALS, INC.] 2 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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