CEFACLOR

Product NDC
21695-782
11-digit product format
216950782
Labeler code
21695
Product ID
21695-782_9e8890f0-e04a-4555-ac8d-d1b792a5c276
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFACLOR
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA064164
Marketing category
ANDA
Marketing start
1997-10-02
Marketing end
0000-00-00
Substance
CEFACLOR
Active strength
250 mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-782IInactivated by FDA2026-08-17
excluded packagepackage21695-78221695-782-15IInactivated by FDA2026-08-17

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 · 44 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 packagepackage21695-782-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-782-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-782-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-782-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-782-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-782-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-782-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-782-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-782-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-782-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-782-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-782-15557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-782-158af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-782-15834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-782-151332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-782-15fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-782-1586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-782-15bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-782-158dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-782-15e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-782-159bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-782-15110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A064164-001CEFACLORCEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-023f01610625f2…
2019-09-15 20:21 UTC2019-09A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064164-001CEFACLOREQ 250MG BASE/5MLFOR SUSPENSION / ORAL1997-10-02e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57d340b5-4768-6bd5-e047-9a70a6cc1ce7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-782-152019-09-24C16284748780-1934fe258-4b18-48b1-e053-8cdaa90a720aCEFACLOR CAPSULES USP AND CEFACLOR FOR ORAL SUSPENSION USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-782-15CEFACLOR150 mL in 1 BOTTLESUSPENSION1501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CefaclorACTIVE INGREDIENT69K7K19H4LCEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CefaclorACTIVE MOIETY69K7K19H4LCEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
citric acidINACTIVE INGREDIENT2968PHW8QPCEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VCEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
sucroseINACTIVE INGREDIENTC151H8M554CEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-782CEFACLOR SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110726_9e8890f0-e04a-4555-ac8d-d1b792a5c276.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313888cefaclor 250 MG in 5 mL Oral SuspensionPSN9e8890f0-e04a-4555-ac8d-d1b792a5c2761
313888cefaclor 50 MG/ML Oral SuspensionSCD9e8890f0-e04a-4555-ac8d-d1b792a5c2761
313888cefaclor (as cefaclor monohydrate) 50 MG/ML Oral SuspensionSY9e8890f0-e04a-4555-ac8d-d1b792a5c2761
313888cefaclor 250 MG per 5 ML Oral SuspensionSY9e8890f0-e04a-4555-ac8d-d1b792a5c2761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-782-1521695078215150 mL in 1 BOTTLE150 mlHistorical