Home NDC 55289-890 Clindamycin Hydrochloride
Product NDC 55289-890
11-digit product format 552890890
Labeler code 55289
Product ID 55289-890_d293ec87-1127-c864-e053-2a95a90a0335
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA063083
Marketing category ANDA
Marketing start 2014-09-09
Marketing end 0000-00-00
Substance CLINDAMYCIN HYDROCHLORIDE
Active strength 300 mg/1
Pharmacologic classes Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 120 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A063083-001 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 A063083-002 CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 1991-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL 2003-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1991-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2003-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1991-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2003-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1991-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2003-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1991-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2003-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A063083-001 CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 1991-07-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A063083-002 CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE CAPSULE / ORAL AB 2003-03-18 bb7c543d1eb4…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLINDAMYCIN HYDROCHLORIDE ACTIVE INGREDIENT T20OQ1YN1W CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 CLINDAMYCIN ACTIVE MOIETY 3U02EL437C CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 GELATIN INACTIVE INGREDIENT 2G86QN327L CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-890-04 55289089004 4 CAPSULE in 1 BOTTLE, PLASTIC (55289-890-04) 4 capsule 2017-04-10 0000-00-00 No No Current 55289-890-09 55289089009 9 CAPSULE in 1 BOTTLE, PLASTIC (55289-890-09) 9 capsule 2014-09-10 0000-00-00 No No Current 55289-890-15 55289089015 15 CAPSULE in 1 BOTTLE, PLASTIC (55289-890-15) 15 capsule 2014-09-10 0000-00-00 No No Current 55289-890-20 55289089020 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-890-20) 20 capsule 2014-09-10 0000-00-00 No No Current 55289-890-21 55289089021 21 CAPSULE in 1 BOTTLE, PLASTIC (55289-890-21) 21 capsule 2017-02-10 0000-00-00 No No Current 55289-890-28 55289089028 28 CAPSULE in 1 BOTTLE, PLASTIC (55289-890-28) 28 capsule 2014-09-10 0000-00-00 No No Current 55289-890-30 55289089030 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-890-30) 30 capsule 2014-09-10 0000-00-00 No No Current 55289-890-40 55289089040 40 CAPSULE in 1 BOTTLE, PLASTIC (55289-890-40) 40 capsule 2014-09-10 0000-00-00 No No Current 55289-890-56 55289089056 56 CAPSULE in 1 BOTTLE, PLASTIC (55289-890-56) 56 capsule 2014-09-10 0000-00-00 No No Current