Cephalexin

Product NDC
55700-563
11-digit product format
557000563
Labeler code
55700
Product ID
55700-563_26b0f8ec-a1aa-4115-8176-8be70cbfe733
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA065326
Marketing category
ANDA
Marketing start
2007-04-12
Marketing end
0000-00-00
Substance
CEPHALEXIN
Active strength
250 mg/5mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct55700-563DDiscontinued by firm2026-08-03
excluded packagepackage55700-56355700-563-00DDiscontinued 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 · 24 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 packagepackage55700-563-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-563-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-563-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-563-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-563-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-563-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-563-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-563-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-563-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-563-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-563-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-563-00557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065326-001CEPHALEXINCEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10
A065326-002CEPHALEXINCEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORAL2006-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065326-001CEPHALEXINEQ 125MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-10782e0a99824c…
2021-12-28 21:50 UTC2021-12A065326-002CEPHALEXINEQ 250MG BASE/5MLFOR SUSPENSION / ORALAB2006-07-10782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-04 05:41 UTC2022-04A065326-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065326-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065326-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065326-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065326-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065326-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065326-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065326-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065326-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065326-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065326-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A065326-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065326-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065326-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065326-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065326-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065326-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A065326-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065326-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065326-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065326-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065326-002AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-563-00ML - Milliliter55700-5636dcf5017-0f03-476e-a675-658d08bcbb0212018-01-12