Home NDC 59651-566 DICLOXACILLIN SODIUM
Product NDC 59651-566
11-digit product format 596510566
Labeler code 59651
Product ID 59651-566_faee6e2d-1b9c-4121-bc22-41313539b366
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DICLOXACILLIN SODIUM
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA216845
Marketing category ANDA
Marketing start 2022-09-23
Substance DICLOXACILLIN SODIUM
Active strength 500 mg/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216845-001 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 A216845-002 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 52 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 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base DICLOXACILLIN SODIUM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOXACILLIN SODIUM 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4HZT2V9KX0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197595 Internal RxNorm lookup 197596 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-566-01 DICLOXACILLIN SODIUM 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-566 DICLOXACILLIN SODIUM CAPSULE [AUROBINDO PHARMA LIMITED] 2 Current NDC, Legacy NDC, 1 package rows 20231229_9074b5a6-850c-4144-9097-bb21073ee54d.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 59651-566-01 59651056601 100 CAPSULE in 1 BOTTLE (59651-566-01) 100 capsule 2022-09-23 0000-00-00 No No Current