Home NDC 25021-115-02 Clindamycin
Product NDC 25021-115
Requested package NDC 25021-115-02
11-digit product format 250210115
Labeler code 25021
Product ID 25021-115_ca8ce6e9-feae-4a33-a380-64061313d704
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Phosphate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA090108
Marketing category ANDA
Marketing start 2012-05-15
Marketing end 2027-01-31
Substance CLINDAMYCIN PHOSPHATE
Active strength 150 mg/mL
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A090108-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090108-001 AP
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 · 44 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 2026-10-15 13:18:30 2026-09 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090108-001 CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE / INJECTION AP 2011-09-30 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Clindamycin Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 150 mg/mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1737244 Internal RxNorm lookup 1737578 Internal RxNorm lookup 1737581 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 25021-115-02 Clindamycin 2 mL in 1 VIAL INJECTION, SOLUTION 2 21 25021-115-02 Clindamycin 25 in 1 CARTON INJECTION, SOLUTION 25 21 25021-115-04 Clindamycin 4 mL in 1 VIAL INJECTION, SOLUTION 4 21 25021-115-04 Clindamycin 25 in 1 CARTON INJECTION, SOLUTION 25 21 25021-115-06 Clindamycin 25 in 1 CARTON INJECTION, SOLUTION 25 21 25021-115-06 Clindamycin 6 mL in 1 VIAL INJECTION, SOLUTION 6 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded clindamycin phosphate ACTIVE INGREDIENT EH6D7113I8 CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 clindamycin ACTIVE MOIETY 3U02EL437C CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 edetate disodium INACTIVE INGREDIENT 7FLD91C86K CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 hydrochloric acid INACTIVE INGREDIENT QTT17582CB CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 12 clindamycin phosphate ACTIVE INGREDIENT EH6D7113I8 CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 11 clindamycin ACTIVE MOIETY 3U02EL437C CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 11 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 11 edetate disodium INACTIVE INGREDIENT 7FLD91C86K CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 11 hydrochloric acid INACTIVE INGREDIENT QTT17582CB CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 11 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-115 CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 21 Current NDC, Legacy NDC, 6 package rows 20241025_7a6967b3-5563-4bed-9eee-d400f800e799.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clindamycin CLINDAMYCIN PHOSPHATE Henry Schein, Inc. 8a4e2ba4-90e6-48e8-a943-0c5d3f169780 2026-02-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090108 application number: ANDA090108 Clindamycin CLINDAMYCIN PHOSPHATE Medical Purchasing Solutions, LLC 9e500a08-0339-eb6b-e053-2a95a90a130c 2023-05-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090108 application number: ANDA090108 Clindamycin CLINDAMYCIN PHOSPHATE Medical Purchasing Solutions, LLC 9e4fc2d5-985a-3734-e053-2995a90aef5b 2023-05-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090108 application number: ANDA090108 Clindamycin CLINDAMYCIN PHOSPHATE Medical Purchasing Solutions, LLC dc8b8a09-3eed-1998-e053-2995a90a2f60 2023-05-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090108 application number: ANDA090108
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 25021-115-02 25021011502 25 VIAL in 1 CARTON (25021-115-02) / 2 mL in 1 VIAL 25 vial 2012-05-15 2026-12-31 No No Current