Application 065434

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFDINIRCEFDINIRCAPSULE;ORAL300MGNoNo

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…

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
ndc (product): 68788-7339
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
ndc (product): 68071-5145
CefdinirCEFDINIRPD-Rx Pharmaceuticals, Inc.e296387e-eb20-4451-a184-f91748a4e9c72025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
ndc (product): 43063-959
CefdinirCEFDINIRPD-Rx Pharmaceuticals, Inc.f4f62b64-5350-4b4e-b8f2-381f54a0cd102025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
ndc (product): 43063-964
CefdinirCEFDINIRPD-Rx Pharmaceuticals, Inc.463084e5-908d-4bbc-b542-10b98211e28e2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
ndc (product): 72789-054
CefdinirCEFDINIRPD-Rx Pharmaceuticals, Inc.3c2130f9-a0d8-4a4e-bcad-36379202b7bb2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
ndc (product): 72789-061
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
ndc (product): 68071-4007
CefdinirCEFDINIRNuCare Pharmaceuticals,Inc.8c3b89a9-cb3f-5960-e053-2995a90aaeee2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
ndc (product): 68071-4946
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
ndc (product): 65862-177
CefdinirCEFDINIRA-S Medication Solutions7c25ae35-61f4-4aef-a8d9-8de77b02ab802023-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
ndc (product): 50090-2719
CefdinirCEFDINIRProficient Rx LP506bcf51-3b7e-4fc0-b22e-a5b726471e3a2023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
ndc (product): 71205-224
CefdinirCEFDINIRBluePoint Laboratoriese342b7cf-f527-476e-8119-b1fd81c58b552023-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065434
application number: ANDA065434
ndc (product): 68001-362

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 80 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-194CefdinirCefdinirBlenheim Pharmacal, Inc.ANDACurrent
16714-391CefdinirCefdinirNorthStar Rx LLCANDACurrent
16714-391CefdinirCefdinirNorthStar Rx LLCANDACurrent
16714-391CefdinirCefdinirNorthStar Rx LLCANDACurrent
21695-620CefdinirCefdinirRebel Distributors CorpANDACurrent
43063-959CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-959CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-959CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-959CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-959CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-959CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-959CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-959CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-964CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-964CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-964CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-964CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-964CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-964CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-964CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1031CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-2636CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-2719CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-2719CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-2719CefdinirCefdinirA-S Medication SolutionsANDACurrent
50090-2719CefdinirCefdinirA-S Medication SolutionsANDACurrent
52959-134CefdinirCefdinirH.J. Harkins Company, Inc.ANDACurrent
53002-1526CefdinirCefdinirRPK Pharmaceuticals, Inc.ANDACurrent
53002-1526CefdinirCefdinirRPK Pharmaceuticals, Inc.ANDACurrent
55700-171CefdinirCefdinirLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-525CefdinirCefdinirLake Erie Medical DBA Quality Care Products LLCANDACurrent
57237-099CefdinirCefdinirRising Health, LLCANDACurrent
57237-099CefdinirCefdinirRising Health, LLCANDACurrent
57237-099CefdinirCefdinirRising Health, LLCANDACurrent
61919-840CEFDINIRCEFDINIRDirectRXANDACurrent
61919-840CEFDINIRCEFDINIRDirectRXANDACurrent
61919-840CEFDINIRCEFDINIRDirectRXANDACurrent
65862-177CefdinirCefdinirAurobindo Pharma LimitedANDACurrent
65862-177CefdinirCefdinirAurobindo Pharma LimitedANDACurrent
65862-177CefdinirCefdinirAurobindo Pharma LimitedANDACurrent
65862-177CefdinirCefdinirAurobindo Pharma LimitedANDACurrent
67296-1216CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
67296-1216CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
67296-1216CefdinirCefdinirRedPharm Drug, Inc.ANDACurrent
68001-362CefdinirCefdinirBluePoint LaboratoriesANDACurrent
68071-4007CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4007CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4946CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4946CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5145CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5145CefdinirCefdinirNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7339CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7339CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7339CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7339CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7375CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7606CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
68788-7606CefdinirCefdinirPreferred Pharmaceuticals Inc.ANDACurrent
70518-1213CefdinirCefdinirREMEDYREPACK INC.ANDACurrent
70518-1213CefdinirCefdinirREMEDYREPACK INC.ANDACurrent
70518-1213CefdinirCefdinirREMEDYREPACK INC.ANDACurrent
70518-2537CefdinirCefdinirREMEDYREPACK INC.ANDACurrent
70518-2537CefdinirCefdinirREMEDYREPACK INC.ANDACurrent
70518-2537CefdinirCefdinirREMEDYREPACK INC.ANDACurrent
70934-044CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-044CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-062CefdinirCefdinirDenton Pharma, Inc.ANDACurrent
70934-062CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-062CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-062CefdinirCefdinirDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-224CefdinirCefdinirProficient Rx LPANDACurrent
71205-224CefdinirCefdinirProficient Rx LPANDACurrent
71205-224CefdinirCefdinirProficient Rx LPANDACurrent
71205-224CefdinirCefdinirProficient Rx LPANDACurrent
72789-054CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-054CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-054CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-061CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-061CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-061CefdinirCefdinirPD-Rx Pharmaceuticals, Inc.ANDACurrent