Cefdinir

Product NDC
57237-099
11-digit product format
572370099
Labeler code
57237
Product ID
57237-099_084623a7-ebe0-4468-9a4b-9fd016e96c3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA065434
Marketing category
ANDA
Marketing start
2008-01-07
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
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…

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
a5594006-8e37-459e-8e85-7e2a83d7a57eAvailable 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
57237-099-60Cefdinir60 in 1 BOTTLECAPSULE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-099-60EA - Each57237-0996d684f7c-85f4-46fc-9878-cc7450d8f1d112015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFDINIRACTIVE INGREDIENTCI0FAO63WCCEFDINIR CAPSULE [CITRON PHARMA LLC]1
CEFDINIRACTIVE MOIETYCI0FAO63WCCEFDINIR CAPSULE [CITRON PHARMA LLC]1
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFDINIR CAPSULE [CITRON PHARMA LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFDINIR CAPSULE [CITRON PHARMA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFDINIR CAPSULE [CITRON PHARMA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFDINIR CAPSULE [CITRON PHARMA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCEFDINIR CAPSULE [CITRON PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFDINIR CAPSULE [CITRON PHARMA LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OCEFDINIR CAPSULE [CITRON PHARMA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFDINIR CAPSULE [CITRON PHARMA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFDINIR CAPSULE [CITRON PHARMA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFDINIR CAPSULE [CITRON PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-099CEFDINIR CAPSULE [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 1 package rows20240215_a5594006-8e37-459e-8e85-7e2a83d7a57e.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
ndc (product): 57237-099
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 CapsulePSN463084e5-908d-4bbc-b542-10b98211e28e14
200346cefdinir 300 MG Oral CapsulePSN7c25ae35-61f4-4aef-a8d9-8de77b02ab8014
200346cefdinir 300 MG Oral CapsuleSCD463084e5-908d-4bbc-b542-10b98211e28e14
200346cefdinir 300 MG Oral CapsuleSCD7c25ae35-61f4-4aef-a8d9-8de77b02ab8014
200346cefdinir 300 MG Oral CapsulePSN3c2130f9-a0d8-4a4e-bcad-36379202b7bb13
200346cefdinir 300 MG Oral CapsuleSCD3c2130f9-a0d8-4a4e-bcad-36379202b7bb13
200346cefdinir 300 MG Oral CapsulePSNa5594006-8e37-459e-8e85-7e2a83d7a57e9
200346cefdinir 300 MG Oral CapsuleSCDa5594006-8e37-459e-8e85-7e2a83d7a57e9
200346cefdinir 300 MG Oral CapsulePSNc3892cd7-0e98-4ba3-a845-4aedf6c2a8308
200346cefdinir 300 MG Oral CapsuleSCDc3892cd7-0e98-4ba3-a845-4aedf6c2a8308
200346cefdinir 300 MG Oral CapsulePSNeb354221-c476-41cb-ad87-52423f81d6987
200346cefdinir 300 MG Oral CapsulePSN54b06071-f3cb-5627-e054-00144ff8d46c7
200346cefdinir 300 MG Oral CapsuleSCDeb354221-c476-41cb-ad87-52423f81d6987
200346cefdinir 300 MG Oral CapsuleSCD54b06071-f3cb-5627-e054-00144ff8d46c7
200346cefdinir 300 MG Oral CapsulePSN506bcf51-3b7e-4fc0-b22e-a5b726471e3a5
200346cefdinir 300 MG Oral CapsulePSN4f1be4f6-9fb2-5c19-e054-00144ff8d46c5
200346cefdinir 300 MG Oral CapsulePSN064e3f74-9644-49bd-abef-20e1dd97794e5
200346cefdinir 300 MG Oral CapsuleSCD506bcf51-3b7e-4fc0-b22e-a5b726471e3a5
200346cefdinir 300 MG Oral CapsuleSCD4f1be4f6-9fb2-5c19-e054-00144ff8d46c5
200346cefdinir 300 MG Oral CapsuleSCD064e3f74-9644-49bd-abef-20e1dd97794e5
200346cefdinir 300 MG Oral CapsulePSN87af716a-6564-ceee-e053-2a95a90a66793
200346cefdinir 300 MG Oral CapsulePSN8c3b89a9-cb3f-5960-e053-2995a90aaeee3
200346cefdinir 300 MG Oral CapsuleSCD87af716a-6564-ceee-e053-2a95a90a66793
200346cefdinir 300 MG Oral CapsuleSCD8c3b89a9-cb3f-5960-e053-2995a90aaeee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-099-605723700996060 CAPSULE in 1 BOTTLE (57237-099-60) 60 capsule2008-01-070000-00-00NoNoCurrent