Home NDC 68788-8115 cefdinir
Product NDC 68788-8115
11-digit product format 687888115
Labeler code 68788
Product ID 68788-8115_cf33cd39-8df0-4681-8f01-c39a72e845fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefdinir
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA210534
Marketing category ANDA
Marketing start 2021-12-07
Substance CEFDINIR
Active strength 125 mg/5mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210534-001 CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 A210534-002 CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19
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 · 68 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 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210534-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210534-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2021-02-19 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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 125 mg/5mL
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 309054 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 68788-8115-1 cefdinir 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 7 68788-8115-6 cefdinir 60 mL in 1 BOTTLE POWDER, FOR SUSPENSION 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8115 CEFDINIR POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20250221_2e384d98-642e-4841-9f62-fcea4c242f4e.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 · 5 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 68788-8115-1 68788811501 100 mL in 1 BOTTLE (68788-8115-1) 100 ml 2024-03-21 No No Current 68788-8115-6 68788811506 60 mL in 1 BOTTLE (68788-8115-6) 60 ml 2021-12-07 0000-00-00 No No Current