Home NDC 0781-6078 Cefdinir
Product NDC 0781-6078
11-digit product format 007816078
Labeler code 0781
Product ID 0781-6078_990055e8-68da-4714-8a9b-02fbb244b570
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefdinir
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Sandoz Inc
Application ANDA065337
Marketing category ANDA
Marketing start 2007-04-06
Marketing end 0000-00-00
Substance CEFDINIR
Active strength 250 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A065337-001 CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 A065337-002 CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06
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 3 · 84 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 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065337-001 CEFDINIR 125MG/5ML FOR SUSPENSION / ORAL AB 2007-04-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065337-002 CEFDINIR 250MG/5ML FOR SUSPENSION / ORAL AB RS 2007-04-06 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFDINIR ACTIVE INGREDIENT CI0FAO63WC CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12 CEFDINIR ACTIVE MOIETY CI0FAO63WC CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12 ANHYDROUS TRISODIUM CITRATE INACTIVE INGREDIENT RS7A450LGA CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12 GUAR GUM INACTIVE INGREDIENT E89I1637KE CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12 STRAWBERRY INACTIVE INGREDIENT 4J2TY8Y81V CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CEFDINIR POWDER, FOR SUSPENSION [SANDOZ INC] 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-6078-46 00781607846 100 mL in 1 BOTTLE (0781-6078-46) 100 ml 2007-04-06 0000-00-00 No No Current 0781-6078-61 00781607861 60 mL in 1 BOTTLE (0781-6078-61) 60 ml 2007-04-06 0000-00-00 No No Current