Home NDC 68788-8323 Cefdinir
Product NDC 68788-8323
11-digit product format 687888323
Labeler code 68788
Product ID 68788-8323_cfe64312-8c09-4ea9-ac4d-2e4a017452d8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefdinir
Dosage form CAPSULE
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA065264
Marketing category ANDA
Marketing start 2023-01-23
Substance CEFDINIR
Active strength 300 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065264-001 CEFDINIR CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065264-001 AB
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 · 41 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 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065264-001 CEFDINIR 300MG CAPSULE / ORAL AB 2006-05-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cefdinir
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFDINIR 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CI0FAO63WC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200346 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 68788-8323-2 Cefdinir 20 in 1 BOTTLE CAPSULE 20 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8323 CEFDINIR CAPSULE [PREFERRED PHARMACEUTICALS, INC.] 3 Current NDC, 1 package rows 20250221_8787ea15-bf90-4178-9b0f-08b075f1aa3d.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8323-2 68788832302 20 CAPSULE in 1 BOTTLE (68788-8323-2) 20 capsule 2023-01-23 No No Current