Cefdinir

Product NDC
68180-711
11-digit product format
681800711
Labeler code
68180
Product ID
68180-711_b7fc2102-2e2f-4880-8b1f-7bc2506fd7b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065264
Marketing category
ANDA
Marketing start
2006-05-30
Substance
CEFDINIR
Active strength
300 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065264-001CEFDINIRCEFDINIR300MGCAPSULE / ORALAB2006-05-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A065264-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-193f01610625f2…
2019-09-15 20:21 UTC2019-09A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065264-001CEFDINIR300MGCAPSULE / ORALAB2006-05-19cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065264-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065264-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065264-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065264-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065264-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065264-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065264-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065264-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065264-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065264-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065264-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065264-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065264-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065264-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065264-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065264-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065264-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065264-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065264-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065264-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065264-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065264-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065264-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065264-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065264-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065264-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065264-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065264-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065264-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065264-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065264-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065264-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065264-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065264-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065264-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065264-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065264-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065264-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065264-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065264-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Cefdinir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFDINIR300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CI0FAO63WCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200346Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb7366ce-1778-451f-aba5-65cf73c9b87aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-711-60Cefdinir60 in 1 BOTTLECAPSULE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-711-60EA - Each68180-71165233736-3752-484d-abfd-162e3583aa7112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR CAPSULE [REDPHARM DRUG INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFDINIR CAPSULE [REDPHARM DRUG INC.]2
GELATININACTIVE INGREDIENT2G86QN327LCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR CAPSULE [REDPHARM DRUG INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFDINIR CAPSULE [REDPHARM DRUG INC.]2
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR (CEFDINIR) CAPSULE [LUPIN PHARMACEUTICALS INC]1
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR (CEFDINIR) CAPSULE [LUPIN PHARMACEUTICALS INC]1
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFDINIR (CEFDINIR) CAPSULE [LUPIN PHARMACEUTICALS INC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR (CEFDINIR) CAPSULE [LUPIN PHARMACEUTICALS INC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFDINIR (CEFDINIR) CAPSULE [LUPIN PHARMACEUTICALS INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFDINIR (CEFDINIR) CAPSULE [LUPIN PHARMACEUTICALS INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFDINIR (CEFDINIR) CAPSULE [LUPIN PHARMACEUTICALS INC]1
GELATININACTIVE INGREDIENT2G86QN327LCEFDINIR (CEFDINIR) CAPSULE [LUPIN PHARMACEUTICALS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR (CEFDINIR) CAPSULE [LUPIN PHARMACEUTICALS INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFDINIR (CEFDINIR) CAPSULE [LUPIN PHARMACEUTICALS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-711CEFDINIR CAPSULE [LUPIN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20250130_cb7366ce-1778-451f-aba5-65cf73c9b87a.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefdinirCEFDINIRPreferred Pharmaceuticals, Inc.8787ea15-bf90-4178-9b0f-08b075f1aa3d2026-03-24WarningsExact identifier
application applno (ANDA): 065264
application number: ANDA065264
CefdinirCEFDINIRLupin Pharmaceuticals, Inc.cb7366ce-1778-451f-aba5-65cf73c9b87a2025-10-14WarningsExact identifier
application applno (ANDA): 065264
application number: ANDA065264
ndc (product): 68180-711
CefdinirCEFDINIRNuCare Pharmaceuticals,Inc.86c21cdd-8b94-f4dc-e053-2991aa0a51eb2025-08-20WarningsExact identifier
application applno (ANDA): 065264
application number: ANDA065264
CefdinirCEFDINIRA-S Medication Solutions12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e702025-04-01WarningsExact identifier
application applno (ANDA): 065264
application number: ANDA065264

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSN12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e7011
200346cefdinir 300 MG Oral CapsulePSNbcf04f49-8d0b-4563-9d0f-93939cdf6a6c11
200346cefdinir 300 MG Oral CapsuleSCD12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e7011
200346cefdinir 300 MG Oral CapsuleSCDbcf04f49-8d0b-4563-9d0f-93939cdf6a6c11
200346cefdinir 300 MG Oral CapsulePSNcb7366ce-1778-451f-aba5-65cf73c9b87a7
200346cefdinir 300 MG Oral CapsuleSCDcb7366ce-1778-451f-aba5-65cf73c9b87a7
200346cefdinir 300 MG Oral CapsulePSN86c21cdd-8b94-f4dc-e053-2991aa0a51eb5
200346cefdinir 300 MG Oral CapsuleSCD86c21cdd-8b94-f4dc-e053-2991aa0a51eb5
200346cefdinir 300 MG Oral CapsulePSN8787ea15-bf90-4178-9b0f-08b075f1aa3d4
200346cefdinir 300 MG Oral CapsuleSCD8787ea15-bf90-4178-9b0f-08b075f1aa3d4
200346cefdinir 300 MG Oral CapsulePSN236cea6b-c72e-43fa-bbcb-187a061e3a332
200346cefdinir 300 MG Oral CapsuleSCD236cea6b-c72e-43fa-bbcb-187a061e3a332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-711-606818007116060 CAPSULE in 1 BOTTLE (68180-711-60) 60 capsule2006-05-300000-00-00NoNoCurrent