Cephalexin

Product NDC
70518-3448
Requested package NDC
70518-3448-2
11-digit product format
705183448
Labeler code
70518
Product ID
70518-3448_4f09bcc9-4adc-f8ae-e063-6294a90a4c35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2021-07-21
Substance
CEPHALEXIN
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-344870518-3448-2DDiscontinued by firm2026-08-10

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
A065229-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25
A065229-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065229-001AB
A065229-002AB

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 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 UTC2026-02A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065229-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB2005-11-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A065229-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB2005-11-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065229-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065229-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065229-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065229-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065229-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065229-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065229-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065229-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065229-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065229-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065229-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065229-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065229-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065229-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065229-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065229-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065229-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065229-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065229-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065229-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065229-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065229-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065229-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065229-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065229-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065229-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065229-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065229-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065229-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Cephalexin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEPHALEXIN500 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309114Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3bb8222-161e-4d9c-8e08-7e22ad65bf72Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dfa3f520-409c-432e-b6d3-9250d468c772Product name120250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6Product name120190628
398aa563-bb78-fe0f-46a8-757c40ef28bfProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3448-0Cephalexin100 in 1 BOXCAPSULE10011
70518-3448-1Cephalexin1 in 1 POUCHCAPSULE111
70518-3448-2Cephalexin30 in 1 BLISTER PACKCAPSULE3011
70518-3448-3Cephalexin20 in 1 BOTTLE, PLASTICCAPSULE2011
70518-3448-4Cephalexin21 in 1 BOTTLE, PLASTICCAPSULE2111
70518-3448-5Cephalexin30 in 1 BOTTLE, PLASTICCAPSULE3011
70518-3448-6Cephalexin14 in 1 BOTTLE, PLASTICCAPSULE1411
70518-3448-7Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE2811
70518-3448-8Cephalexin40 in 1 BOTTLE, PLASTICCAPSULE4011
70518-3448-9Cephalexin28 in 1 BOTTLE, PLASTICCAPSULE2811

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3448-4EA - Each70518-3448b52abdb9-a05b-4a15-80ef-38ac3b23602112026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3448CEPHALEXIN CAPSULE [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 10 package rows20241006_b3bb8222-161e-4d9c-8e08-7e22ad65bf72.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
CephalexinCEPHALEXINREMEDYREPACK INC.b3bb8222-161e-4d9c-8e08-7e22ad65bf722026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
ndc (package): 70518-3448-2
ndc (product): 70518-3448
ndc11 (package): 70518344802
CephalexinCEPHALEXINREMEDYREPACK INC.8499aa5a-49b1-4555-bd27-6177d92b261d2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINCoupler LLC508a3401-df0b-0555-e063-6294a90a155a2026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINSportpharm LLC3d5a2665-65da-4b10-9e23-39fc88145da12026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.13444dc7-7da1-4181-a9ac-d95d4a235e6d2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINLupin Pharmaceuticals, Inc.1d3e6d33-5dc2-498e-8efa-e3c4fca15dff2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINADVANCED RX PHARMACY OF TENNESSEE, LLCaf4abf8b-22cc-da58-e053-2a95a90aa7662024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.a33280d4-7caf-f74b-e053-2a95a90a90c32024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc945552cb-90e4-41fb-afe2-8ee8785e94da2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.20f8cc57-231c-4d36-a209-ff9e5735d65c2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e2024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.728c5212-dbd8-8df5-e053-2a91aa0a95792024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINADVANCED RX PHARMACY OF TENNESSEE, LLCaf10128f-021a-14b7-e053-2a95a90a43652024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINAsclemed USA, Inc.6032b68f-16d8-41b6-bd2c-86d5406a757a2022-09-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229
CephalexinCEPHALEXINProficient Rx LPdec3a1ef-1e85-4236-804b-e7a343d3a58f2022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065229
application number: ANDA065229

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNb3bb8222-161e-4d9c-8e08-7e22ad65bf7211
309114cephalexin 500 MG Oral CapsuleSCDb3bb8222-161e-4d9c-8e08-7e22ad65bf7211
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYb3bb8222-161e-4d9c-8e08-7e22ad65bf7211
309114cephalexin 500 MG Oral CapsulePSN3d5a2665-65da-4b10-9e23-39fc88145da13
309114cephalexin 500 MG Oral CapsuleSCD3d5a2665-65da-4b10-9e23-39fc88145da13
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY3d5a2665-65da-4b10-9e23-39fc88145da13
309114cephalexin 500 MG Oral CapsulePSN20f8cc57-231c-4d36-a209-ff9e5735d65c1
309114cephalexin 500 MG Oral CapsuleSCD20f8cc57-231c-4d36-a209-ff9e5735d65c1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY20f8cc57-231c-4d36-a209-ff9e5735d65c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3448-27051834480230 CAPSULE in 1 BLISTER PACK (70518-3448-2) 30 capsule2022-08-110000-00-00NoNoCurrent