Cefdinir

Product NDC
67877-524
11-digit product format
678770524
Labeler code
67877
Product ID
67877-524_ed161b31-baa3-458b-a83b-fe301ad5c455
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA210220
Marketing category
ANDA
Marketing start
2021-02-20
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
2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67877-524DDiscontinued by firm2026-08-03
excluded packagepackage67877-52467877-524-01DDiscontinued by firm2026-08-03
excluded packagepackage67877-52467877-524-38DDiscontinued by firm2026-08-03
excluded packagepackage67877-52467877-524-60DDiscontinued by firm2026-08-03

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67877-524-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67877-524-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67877-524-38d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67877-524-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67877-524-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67877-524-38f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67877-524-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67877-524-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67877-524-382ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67877-524-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67877-524-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67877-524-38a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67877-524-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67877-524-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67877-524-38cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67877-524-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67877-524-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67877-524-38cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67877-524-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67877-524-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67877-524-38302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67877-524-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67877-524-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67877-524-38ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67877-524-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67877-524-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67877-524-380efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67877-524-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67877-524-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67877-524-38ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67877-524-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67877-524-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67877-524-38367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67877-524-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67877-524-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67877-524-38557ba5c1ecfa…9c80585c8c6e…

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…

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-524-0167877052401100 CAPSULE in 1 BOTTLE (67877-524-01) 100 capsule2021-02-200000-00-00NoNoCurrent
67877-524-386787705243810 BLISTER PACK in 1 CARTON (67877-524-38) > 10 CAPSULE in 1 BLISTER PACK (67877-524-33) 10 blister pack2021-02-200000-00-00NoNoCurrent
67877-524-606787705246060 CAPSULE in 1 BOTTLE (67877-524-60) 60 capsule2021-02-200000-00-00NoNoCurrent