Home NDC 42291-043 Cefdinir
Product NDC 42291-043
11-digit product format 422910043
Labeler code 42291
Product ID 42291-043_484c12cb-6b62-1ca6-e063-6394a90a7cfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefdinir
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA065368
Marketing category ANDA
Marketing start 2024-06-13
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 A065368-001 CEFDINIR CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065368-001 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 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065368-001 CEFDINIR 300MG CAPSULE / ORAL AB 2007-05-09 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 42291-043-60 Cefdinir 60 in 1 BOTTLE CAPSULE 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-043 CEFDINIR CAPSULE [AVKARE] 1 Current NDC, 1 package rows 20240615_1acc5d17-10a4-e23d-e063-6394a90a52c3.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 · 2 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 42291-043-60 42291004360 60 CAPSULE in 1 BOTTLE (42291-043-60) 60 capsule 2024-06-13 No No Current