Cephalexin

Product NDC
50090-4422
11-digit product format
500904422
Labeler code
50090
Product ID
50090-4422_4c7f0c98-0d84-414e-808a-f2e6f55227d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA062702
Marketing category
ANDA
Marketing start
1990-09-30
Substance
CEPHALEXIN
Active strength
500 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
A062702-001CEPHALEXINCEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13
A062702-002CEPHALEXINCEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062702-001AB
A062702-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062702-001CEPHALEXINEQ 250MG BASECAPSULE / ORALAB1987-02-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062702-002CEPHALEXINEQ 500MG BASECAPSULE / ORALAB1987-02-13bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A062702-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A062702-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062702-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062702-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062702-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062702-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062702-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062702-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062702-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062702-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062702-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062702-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062702-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062702-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062702-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062702-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062702-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062702-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062702-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062702-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062702-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062702-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062702-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062702-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062702-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062702-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062702-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062702-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062702-002AB1bb7c543d1eb4…

Additional Listing Data#

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

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
fc426d0d-9774-4189-8d83-89aa85d926bbAvailable 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
50090-4422-0Cephalexin20 in 1 BOTTLECAPSULE2020
50090-4422-1Cephalexin28 in 1 BOTTLECAPSULE2820
50090-4422-2Cephalexin40 in 1 BOTTLECAPSULE4020
50090-4422-3Cephalexin14 in 1 BOTTLECAPSULE1420
50090-4422-5Cephalexin10 in 1 BOTTLECAPSULE1020
50090-4422-6Cephalexin30 in 1 BOTTLECAPSULE3020
50090-4422-7Cephalexin100 in 1 BOTTLECAPSULE10020
50090-4422-8Cephalexin4 in 1 BOTTLECAPSULE420

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4422-0EA - Each50090-4422f65016b9-d4fb-4d9b-b179-6693ffaffecf12024-06-10
50090-4422-1EA - Each50090-4422534a794e-9463-4d8c-87df-ee98a8afbd3312024-06-10
50090-4422-2EA - Each50090-4422d147840c-77d6-4d50-8dba-b3990bb7fdc312024-06-10
50090-4422-3EA - Each50090-4422334e8342-05eb-4f0c-bee3-a1b2ff39a5be12024-06-10
50090-4422-5EA - Each50090-4422f50f476f-84d8-49b8-833c-de5e2f80b88212024-06-10
50090-4422-6EA - Each50090-44221af88dd0-1e3a-4487-b58c-4f0c86815c2312024-06-10
50090-4422-7EA - Each50090-4422c73d6150-f407-4091-8abd-196f484ba60c12024-06-10
50090-4422-8EA - Each50090-44226f807215-a25a-45c1-9960-0d6fc8882f8012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4422CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]20Current NDC, 8 package rows20240523_fc426d0d-9774-4189-8d83-89aa85d926bb.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.b73593ce-0b1f-4371-bae1-140742de3b422026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINUnit Dose Solutions, Inc.53704ffd-b4f6-8b61-e063-6394a90a01f92026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.ad676021-44f3-4a97-a3dc-28a62fe982bb2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.3fed2817-fc0d-43cd-9f02-948fbc76672c2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINAVKARE74f83298-57f7-4166-8dd8-db3e556a68d82025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINQPharma Ince8b3ece4-cf73-416c-8767-68f425df35f82025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINQPharma Inc4e9a8ed3-c490-4a0e-bb29-5eea506f893b2025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.6ce11859-aa21-4b3f-bd59-3cd26deca82b2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINA-S Medication Solutionsbff3912c-c39c-40c0-98d2-27c3d506c24d2025-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINNuCare Pharmaceuticals,Inc.ade02343-3e4b-b1f1-e053-2995a90ac5fe2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINA-S Medication Solutionsfc426d0d-9774-4189-8d83-89aa85d926bb2024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
ndc (product): 50090-4422
CephalexinCEPHALEXINA-S Medication Solutions5b7666f3-4014-45ce-8387-3298d9fe6d252024-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINBryant Ranch Prepack18518154-30ba-48a4-852a-3a77230300712023-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINProficient Rx LPada7b8a5-98f4-454c-b38f-92192d4db33f2021-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702
CephalexinCEPHALEXINTeva Pharmaceuticals USA, Inc.19307ff0-71de-477b-965d-ea243e5ede3a2020-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062702
application number: ANDA062702

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309114cephalexin 500 MG Oral CapsulePSNfc426d0d-9774-4189-8d83-89aa85d926bb20
309114cephalexin 500 MG Oral CapsuleSCDfc426d0d-9774-4189-8d83-89aa85d926bb20
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYfc426d0d-9774-4189-8d83-89aa85d926bb20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-4422-05009044220020 CAPSULE in 1 BOTTLE (50090-4422-0) 20 capsule2019-07-19NoNoCurrent
50090-4422-15009044220128 CAPSULE in 1 BOTTLE (50090-4422-1) 28 capsule2024-05-17NoNoCurrent
50090-4422-25009044220240 CAPSULE in 1 BOTTLE (50090-4422-2) 40 capsule2019-07-19NoNoCurrent
50090-4422-35009044220314 CAPSULE in 1 BOTTLE (50090-4422-3) 14 capsule2019-07-19NoNoCurrent
50090-4422-55009044220510 CAPSULE in 1 BOTTLE (50090-4422-5) 10 capsule2024-05-17NoNoCurrent
50090-4422-65009044220630 CAPSULE in 1 BOTTLE (50090-4422-6) 30 capsule2019-07-19NoNoCurrent
50090-4422-750090442207100 CAPSULE in 1 BOTTLE (50090-4422-7) 100 capsule2024-05-17NoNoCurrent
50090-4422-8500904422084 CAPSULE in 1 BOTTLE (50090-4422-8) 4 capsule2024-05-17NoNoCurrent