Cefdinir

Product NDC
53002-1526
Requested package NDC
53002-1526-1
11-digit product format
530021526
Labeler code
53002
Product ID
53002-1526_7e4ab69e-495d-4b51-bb1f-4f92b46b6d2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065434
Marketing category
ANDA
Marketing start
2008-01-07
Marketing end
0000-00-00
Substance
CEFDINIR
Active strength
300 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-152653002-1526-1IInactivated 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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A065434-001CEFDINIRCEFDINIR300MGCAPSULE / ORALAB2008-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065434-001AB

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 UTC2026-02A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-073f01610625f2…
2019-09-15 20:21 UTC2019-09A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065434-001CEFDINIR300MGCAPSULE / ORALAB2008-01-07cb3db0bc1861…

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 UTC2026-02A065434-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065434-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065434-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065434-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065434-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065434-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065434-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065434-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065434-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065434-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065434-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065434-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065434-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065434-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065434-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065434-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065434-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065434-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065434-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065434-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065434-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065434-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065434-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065434-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065434-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065434-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065434-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065434-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065434-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065434-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065434-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065434-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065434-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065434-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065434-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065434-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065434-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065434-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065434-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065434-001AB1cb3db0bc1861…

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
53002-1526-1Cefdinir10 in 1 BOTTLECAPSULE105
53002-1526-2Cefdinir20 in 1 BOTTLECAPSULE205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1526CEFDINIR CAPSULE [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_064e3f74-9644-49bd-abef-20e1dd97794e.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefdinirCEFDINIRNuCare Pharmaceuticals, Inc.5128dc70-f3cd-25c0-e063-6294a90aa52f2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRPreferred Pharmaceuticals Inc.c3892cd7-0e98-4ba3-a845-4aedf6c2a8302026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRPreferred Pharmaceuticals Inc.2da6eb80-63b0-4377-8d7b-865733ebbab12026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRPD-Rx Pharmaceuticals, Inc.a5f028d5-ab33-491e-a385-56e79e1651502026-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRREMEDYREPACK INC.eb354221-c476-41cb-ad87-52423f81d6982026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRNuCare Pharmaceuticals,Inc.9ba5cb2d-6272-27de-e053-2995a90a58c82025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRPD-Rx Pharmaceuticals, Inc.e296387e-eb20-4451-a184-f91748a4e9c72025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRPD-Rx Pharmaceuticals, Inc.f4f62b64-5350-4b4e-b8f2-381f54a0cd102025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRPD-Rx Pharmaceuticals, Inc.463084e5-908d-4bbc-b542-10b98211e28e2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRPD-Rx Pharmaceuticals, Inc.3c2130f9-a0d8-4a4e-bcad-36379202b7bb2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRDirect_Rxf431ad55-24c8-e12a-e053-2a95a90aa0432025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRNuCare Pharmaceuticals,Inc.54b06071-f3cb-5627-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRNuCare Pharmaceuticals,Inc.8c3b89a9-cb3f-5960-e053-2995a90aaeee2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRRising Pharma Holdings, Inc.a5594006-8e37-459e-8e85-7e2a83d7a57e2024-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRAurobindo Pharma Limiteddf26edb0-9bd6-449c-a187-0be0c9e2600c2024-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRA-S Medication Solutions7c25ae35-61f4-4aef-a8d9-8de77b02ab802023-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRProficient Rx LP506bcf51-3b7e-4fc0-b22e-a5b726471e3a2023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
CefdinirCEFDINIRBluePoint Laboratoriese342b7cf-f527-476e-8119-b1fd81c58b552023-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSN064e3f74-9644-49bd-abef-20e1dd97794e5
200346cefdinir 300 MG Oral CapsuleSCD064e3f74-9644-49bd-abef-20e1dd97794e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1526-15300215260110 CAPSULE in 1 BOTTLE (53002-1526-1) 10 capsule2018-10-010000-00-00NoNoCurrent