Cefdinir

Product NDC
67296-1448
11-digit product format
672961448
Labeler code
67296
Product ID
67296-1448_2c623bbf-8af9-a70c-e063-6294a90a6d94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
Redpharm Drug, Inc.
Application
ANDA210220
Marketing category
ANDA
Marketing start
2021-02-20
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1448IInactivated by FDA2026-08-03
excluded packagepackage67296-144867296-1448-7IInactivated by FDA2026-08-03

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1448-7IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1448-7IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1448-7IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1448-7IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1448-7IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1448-7IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1448-7UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1448-7UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1448-7UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A210220-001CEFDINIRCEFDINIR300MGCAPSULE / ORALAB2021-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210220-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-194b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-1987673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210220-001CEFDINIR300MGCAPSULE / ORALAB2021-02-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210220-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210220-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210220-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210220-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210220-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210220-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210220-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210220-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210220-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210220-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210220-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210220-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210220-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210220-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210220-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210220-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210220-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210220-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210220-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210220-001AB187673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210220-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210220-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210220-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210220-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210220-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210220-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210220-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210220-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210220-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210220-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210220-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210220-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210220-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210220-001AB1a50c72e98297…

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
f3d228c8-bde9-ffcf-e053-2a95a90aa5c4Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1448-1Cefdinir10 in 1 BOTTLECAPSULE103
67296-1448-2Cefdinir20 in 1 BOTTLECAPSULE203
67296-1448-7Cefdinir14 in 1 BOTTLECAPSULE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1448CEFDINIR CAPSULE [REDPHARM DRUG, INC.]3Current NDC, 2 package rows20250124_f3d228c8-bde9-ffcf-e053-2a95a90aa5c4.zip
67296-1448CEFDINIR CAPSULE [REDPHARM DRUG,]1Current NDC, 1 package rows20230204_f3cdc850-d3bf-1b0e-e053-2a95a90a7a3b.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefdinirCEFDINIRNorthwind Health Company, LLC1d0d50ba-8c2b-855c-e063-6394a90a5c7d2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRProficient Rx LP63d2f931-6896-47e5-905e-4f812d6cb1052026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRREMEDYREPACK INC.a8029f7c-6353-46db-8c8c-c86a9485a14f2026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRNuCare Pharmaceuticals,Inc.c23af6af-a97b-b98d-e053-2995a90ae7802026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRMajor Pharmaceuticalsa0934baf-4745-4546-a63a-d4a660a188b32025-10-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRBryant Ranch Prepack63aa0304-574f-4d37-9fb4-26ffb058fbec2025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRBryant Ranch Prepackd5fd32d8-66de-4a9f-9b83-88b190a903772025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRAscend Laboratories, LLC18888955-4db3-4d0d-939f-eaaa5f2e0dc42025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRPreferred Pharmaceuticals Inc.c5142dca-4fb8-467d-910a-e8228e694c942025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRRedpharm Drug, Inc.f3d228c8-bde9-ffcf-e053-2a95a90aa5c42025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
ndc (product): 67296-1448
CEFDINIRCEFDINIRDirectRxd70b9e1f-908f-b570-e053-2995a90af0982025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRNuCare Pharmaceuticals,Inc.c974d975-8616-3551-e053-2995a90a65f32025-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRAmerican Health Packagingc493e78b-afa3-4f74-8305-75e5f3817df02024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRA-S Medication Solutions10bf69e7-5f7e-4448-9f22-777f137d96662023-12-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220
CefdinirCEFDINIRA-S Medication Solutionsa217d454-4ca0-4b29-8a64-eb9393a852692023-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210220
application number: ANDA210220

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSNf3d228c8-bde9-ffcf-e053-2a95a90aa5c43
200346cefdinir 300 MG Oral CapsuleSCDf3d228c8-bde9-ffcf-e053-2a95a90aa5c43
200346cefdinir 300 MG Oral CapsulePSNf3cdc850-d3bf-1b0e-e053-2a95a90a7a3b1
200346cefdinir 300 MG Oral CapsuleSCDf3cdc850-d3bf-1b0e-e053-2a95a90a7a3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-1448-16729614480110 CAPSULE in 1 BOTTLE (67296-1448-1) 10 capsule2021-02-20NoNoCurrent
67296-1448-26729614480220 CAPSULE in 1 BOTTLE (67296-1448-2) 20 capsule2021-02-20NoNoCurrent
67296-1448-76729614480714 in 1 BOTTLEHistorical