Cephalexin

Product NDC
0093-2238
11-digit product format
000932238
Labeler code
0093
Product ID
0093-2238_39e510b0-2478-4e34-81a1-20f002a6ae35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA063024
Marketing category
ANDA
Marketing start
1990-09-30
Substance
CEPHALEXIN
Active strength
250 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 42.

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
A063024-001CEPHALEXINCEPHALEXINEQ 500MG BASETABLET / ORALABRS1989-01-12
A063024-002CEPHALEXINCEPHALEXINEQ 250MG BASETABLET / ORALAB1989-01-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A063024-001AB
A063024-002AB

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 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALABRS1989-01-12caaa826d4ba7…
2026-08-18 06:07:402026-07A063024-002CEPHALEXINEQ 250MG BASETABLET / ORALAB1989-01-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A063024-002CEPHALEXINEQ 250MG BASETABLET / ORAL1989-01-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063024-002CEPHALEXINEQ 250MG BASETABLET / ORAL1989-01-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-123f01610625f2…
2019-09-15 20:21 UTC2019-09A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A063024-001CEPHALEXINEQ 500MG BASETABLET / ORALRS1989-01-123bdfa0b2c4d7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A063024-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A063024-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A063024-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A063024-002AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OBN7UDS42YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197454Internal RxNorm lookup
309115Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
445b2a87-2e4f-483a-abe8-26fefd67514aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-2238-01Cephalexin100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-2238-01EA - Each0093-2238e5d85d06-1d49-46ac-813b-84fe0c9c37fc12012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-2238CEPHALEXIN TABLET [TEVA PHARMACEUTICALS USA, INC.]4Current NDC, Legacy NDC, 1 package rows20240602_445b2a87-2e4f-483a-abe8-26fefd67514a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CephalexinCEPHALEXINTeva Pharmaceuticals USA, Inc.445b2a87-2e4f-483a-abe8-26fefd67514a2023-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063024
application number: ANDA063024
ndc (product): 0093-2238

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309115cephalexin 250 MG Oral TabletPSN445b2a87-2e4f-483a-abe8-26fefd67514a5
197454cephalexin 500 MG Oral TabletPSN445b2a87-2e4f-483a-abe8-26fefd67514a5
309115cephalexin 250 MG Oral TabletSCD445b2a87-2e4f-483a-abe8-26fefd67514a5
197454cephalexin 500 MG Oral TabletSCD445b2a87-2e4f-483a-abe8-26fefd67514a5
309115cefalexin (as cefalexin monohydrate) 25 MG Oral TabletSY445b2a87-2e4f-483a-abe8-26fefd67514a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-2238-0100093223801100 TABLET in 1 BOTTLE (0093-2238-01) 100 tablet1990-09-300000-00-00NoNoCurrent