Home NDC 67296-2307 DICLOXACILLIN SODIUM
Product NDC 67296-2307
11-digit product format 672962307
Labeler code 67296
Product ID 67296-2307_58e6ee4e-1939-e8bd-e063-6394a90accb8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DICLOXACILLIN SODIUM
Dosage form CAPSULE
Route ORAL
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]
Listing certified through 2027-12-31
Current FDA listing Yes 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 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 · 54 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 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base DICLOXACILLIN SODIUM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOXACILLIN SODIUM 500 mg/1
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 67296-2307-4 67296230704 40 CAPSULE in 1 BOTTLE (67296-2307-4) 40 capsule 2022-09-23 0 Current