Cefdinir

Product NDC
67877-543
11-digit product format
678770543
Labeler code
67877
Product ID
67877-543_88df7b4a-ada5-4fd3-8e16-48053abdf1b2
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
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
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
18888955-4db3-4d0d-939f-eaaa5f2e0dc4Available 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
67877-543-01Cefdinir100 in 1 BOTTLECAPSULE1009
67877-543-33Cefdinir10 in 1 BLISTER PACKCAPSULE109
67877-543-38Cefdinir10 in 1 CARTONCAPSULE109
67877-543-60Cefdinir60 in 1 BOTTLECAPSULE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-543-60EA - Each67877-5431326cf35-3af5-45cc-8b5c-8b51decb0e6912021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-543CEFDINIR CAPSULE [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 4 package rows20231229_18888955-4db3-4d0d-939f-eaaa5f2e0dc4.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
ndc (product): 67877-543
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200346cefdinir 300 MG Oral CapsulePSN63aa0304-574f-4d37-9fb4-26ffb058fbec102
200346cefdinir 300 MG Oral CapsuleSCD63aa0304-574f-4d37-9fb4-26ffb058fbec102
200346cefdinir 300 MG Oral CapsulePSN18888955-4db3-4d0d-939f-eaaa5f2e0dc49
200346cefdinir 300 MG Oral CapsuleSCD18888955-4db3-4d0d-939f-eaaa5f2e0dc49
200346cefdinir 300 MG Oral CapsulePSN10bf69e7-5f7e-4448-9f22-777f137d96665
200346cefdinir 300 MG Oral CapsulePSNc5142dca-4fb8-467d-910a-e8228e694c945
200346cefdinir 300 MG Oral CapsulePSNa8029f7c-6353-46db-8c8c-c86a9485a14f5
200346cefdinir 300 MG Oral CapsuleSCD10bf69e7-5f7e-4448-9f22-777f137d96665
200346cefdinir 300 MG Oral CapsuleSCDc5142dca-4fb8-467d-910a-e8228e694c945
200346cefdinir 300 MG Oral CapsuleSCDa8029f7c-6353-46db-8c8c-c86a9485a14f5
200346cefdinir 300 MG Oral CapsulePSNf3d228c8-bde9-ffcf-e053-2a95a90aa5c43
200346cefdinir 300 MG Oral CapsulePSNd70b9e1f-908f-b570-e053-2995a90af0983
200346cefdinir 300 MG Oral CapsulePSNc974d975-8616-3551-e053-2995a90a65f33
200346cefdinir 300 MG Oral CapsulePSNc23af6af-a97b-b98d-e053-2995a90ae7803
200346cefdinir 300 MG Oral CapsulePSNa217d454-4ca0-4b29-8a64-eb9393a852693
200346cefdinir 300 MG Oral CapsuleSCDa217d454-4ca0-4b29-8a64-eb9393a852693
200346cefdinir 300 MG Oral CapsuleSCDc23af6af-a97b-b98d-e053-2995a90ae7803
200346cefdinir 300 MG Oral CapsuleSCDc974d975-8616-3551-e053-2995a90a65f33
200346cefdinir 300 MG Oral CapsuleSCDd70b9e1f-908f-b570-e053-2995a90af0983
200346cefdinir 300 MG Oral CapsuleSCDf3d228c8-bde9-ffcf-e053-2a95a90aa5c43
200346cefdinir 300 MG Oral CapsulePSN63d2f931-6896-47e5-905e-4f812d6cb1052
200346cefdinir 300 MG Oral CapsulePSNd5fd32d8-66de-4a9f-9b83-88b190a903772
200346cefdinir 300 MG Oral CapsulePSN1d0d50ba-8c2b-855c-e063-6394a90a5c7d2
200346cefdinir 300 MG Oral CapsuleSCD63d2f931-6896-47e5-905e-4f812d6cb1052
200346cefdinir 300 MG Oral CapsuleSCDd5fd32d8-66de-4a9f-9b83-88b190a903772
200346cefdinir 300 MG Oral CapsuleSCD1d0d50ba-8c2b-855c-e063-6394a90a5c7d2
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 startMarketing endSampleExclude flagStatus
67877-543-0167877054301100 CAPSULE in 1 BOTTLE (67877-543-01) 100 capsule2021-02-200000-00-00NoNoCurrent
67877-543-336787705433310 in 1 BLISTER PACKHistorical
67877-543-386787705433810 BLISTER PACK in 1 CARTON (67877-543-38) / 10 CAPSULE in 1 BLISTER PACK (67877-543-33) 10 blister pack2021-02-200000-00-00NoNoCurrent
67877-543-606787705436060 CAPSULE in 1 BOTTLE (67877-543-60) 60 capsule2021-02-200000-00-00NoNoCurrent