Home Applications 061454 Application 061454
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM CAPSULE;ORAL EQ 250MG BASE No No 002 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM CAPSULE;ORAL EQ 125MG BASE No No 003 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM CAPSULE;ORAL EQ 500MG BASE No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A061454-001 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 A061454-002 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 A061454-003 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982
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 4 · 129 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 2026-09-14 22:38:34 2026-08 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A061454-002 DICLOXACILLIN SODIUM EQ 125MG BASE CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A061454-003 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A061454-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL Approved before 1982 301d65b070ca…
Observed Orange Book normalized TE history# 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 · 9 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM Redpharm Drug 58e6ee7a-8237-ec66-e063-6394a90a5cae 2026-08-13 Warnings, Adverse reactions Name fallback brand name: DICLOXACILLIN SODIUM generic name: DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM Chartwell RX, LLC 270c0839-c30c-475d-a505-e70855652c9e 2026-07-23 Warnings, Adverse reactions Name fallback brand name: DICLOXACILLIN SODIUM generic name: DICLOXACILLIN SODIUM Dicloxacillin Sodium DICLOXACILLIN SODIUM PD-Rx Pharmaceuticals, Inc. c17cd62d-ff5d-47ba-8673-3346c7f2365f 2026-05-21 Warnings, Adverse reactions Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM Dicloxacillin Sodium DICLOXACILLIN SODIUM PD-Rx Pharmaceuticals, Inc. 9e2bbe03-44cb-45d1-acdb-b61d9016055e 2025-10-20 Warnings, Adverse reactions Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM Dicloxacillin Sodium DICLOXACILLIN SODIUM PD-Rx Pharmaceuticals, Inc. 24e821aa-85b8-4f5a-aa13-83ff132952ca 2025-10-15 Warnings, Adverse reactions Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM Dicloxacillin Sodium DICLOXACILLIN SODIUM Bryant Ranch Prepack 3e4842ec-773b-4aeb-b37d-1c4e3cf53424 2024-01-18 Warnings, Adverse reactions Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM Aurobindo Pharma Limited 9074b5a6-850c-4144-9097-bb21073ee54d 2023-12-27 Warnings, Adverse reactions Name fallback brand name: DICLOXACILLIN SODIUM generic name: DICLOXACILLIN SODIUM Dicloxacillin Sodium DICLOXACILLIN SODIUM Teva Pharmaceuticals USA, Inc. 8478f242-c715-4984-ac1d-dc79dc28665e 2022-06-22 Warnings, Adverse reactions Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM Dicloxacillin Sodium DICLOXACILLIN SODIUM Asclemed USA, Inc. a4174fda-68f7-4834-be58-dd6b167cf9f0 2020-11-14 Warnings, Adverse reactions Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0440-1380 Dicloxacillin Sodium Dicloxacillin Sodium Liberty Pharmaceuticals, Inc. ANDA Current 0781-2248 Dicloxacillin Sodium Dicloxacillin Sodium Sandoz Inc ANDA Current 0781-2248 Dicloxacillin Sodium Dicloxacillin Sodium Sandoz Inc ANDA Current 0781-2258 Dicloxacillin Sodium Dicloxacillin Sodium Sandoz Inc ANDA Current 0781-2258 Dicloxacillin Sodium Dicloxacillin Sodium Sandoz Inc ANDA Current 21695-124 Dicloxacillin Sodium Dicloxacillin Sodium Rebel Distributors Corp ANDA Current 50090-1702 Dicloxacillin Sodium Dicloxacillin Sodium A-S Medication Solutions ANDA Current 55289-094 Dicloxacillin Sodium Dicloxacillin Sodium PD-Rx Pharmaceuticals, Inc. ANDA Current 63629-1350 Dicloxacillin Sodium Dicloxacillin Sodium Bryant Ranch Prepack ANDA Current 67296-1205 Dicloxacillin Sodium Dicloxacillin Sodium RedPharm Drug, Inc. ANDA Current 67296-1205 Dicloxacillin Sodium Dicloxacillin Sodium RedPharm Drug, Inc. ANDA Current 67296-1205 Dicloxacillin Sodium Dicloxacillin Sodium RedPharm Drug, Inc. ANDA Current