Cephalexin

Product NDC
68180-122
11-digit product format
681800122
Labeler code
68180
Product ID
68180-122_06fa2abb-0eee-4425-8063-b9dfe56c1867
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cephalexin
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA065229
Marketing category
ANDA
Marketing start
2006-01-11
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 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
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309112Internal RxNorm lookup
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
1d3e6d33-5dc2-498e-8efa-e3c4fca15dffAvailable 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
68180-122-01Cephalexin100 in 1 BOTTLECAPSULE1009
68180-122-02Cephalexin500 in 1 BOTTLECAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-122-01EA - Each68180-122a2495790-6fb4-4105-9de8-a9cfc744041012012-07-24
68180-122-02EA - Each68180-1224dc74036-2d8e-4d27-a6a9-55f55f4873e412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [NORTHWIND PHARMACEUTICALS]3
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [NORTHWIND PHARMACEUTICALS]3
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [PROFICIENT RX LP]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [REDPHARM DRUG INC.]2
CEPHALEXINACTIVE INGREDIENTOBN7UDS42YCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CEPHALEXIN ANHYDROUSACTIVE MOIETY5SFF1W6677CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-122CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20201230_1d3e6d33-5dc2-498e-8efa-e3c4fca15dff.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
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
ndc (product): 68180-122
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 CapsulePSNaf10128f-021a-14b7-e053-2a95a90a436512
309114cephalexin 500 MG Oral CapsuleSCDaf10128f-021a-14b7-e053-2a95a90a436512
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYaf10128f-021a-14b7-e053-2a95a90a436512
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 CapsulePSNdec3a1ef-1e85-4236-804b-e7a343d3a58f10
309114cephalexin 500 MG Oral CapsuleSCDdec3a1ef-1e85-4236-804b-e7a343d3a58f10
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYdec3a1ef-1e85-4236-804b-e7a343d3a58f10
309112cephalexin 250 MG Oral CapsulePSNec8f8062-a065-41d8-a2ad-97aa49bf1c279
309112cephalexin 250 MG Oral CapsulePSN1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309114cephalexin 500 MG Oral CapsulePSN1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309114cephalexin 500 MG Oral CapsulePSNec8f8062-a065-41d8-a2ad-97aa49bf1c279
309112cephalexin 250 MG Oral CapsuleSCD1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309112cephalexin 250 MG Oral CapsuleSCDec8f8062-a065-41d8-a2ad-97aa49bf1c279
309114cephalexin 500 MG Oral CapsuleSCDec8f8062-a065-41d8-a2ad-97aa49bf1c279
309114cephalexin 500 MG Oral CapsuleSCD1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYec8f8062-a065-41d8-a2ad-97aa49bf1c279
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSYec8f8062-a065-41d8-a2ad-97aa49bf1c279
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY1d3e6d33-5dc2-498e-8efa-e3c4fca15dff9
309114cephalexin 500 MG Oral CapsulePSNaf4abf8b-22cc-da58-e053-2a95a90aa7667
309114cephalexin 500 MG Oral CapsuleSCDaf4abf8b-22cc-da58-e053-2a95a90aa7667
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYaf4abf8b-22cc-da58-e053-2a95a90aa7667
309114cephalexin 500 MG Oral CapsulePSN8499aa5a-49b1-4555-bd27-6177d92b261d6
309114cephalexin 500 MG Oral CapsuleSCD8499aa5a-49b1-4555-bd27-6177d92b261d6
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY8499aa5a-49b1-4555-bd27-6177d92b261d6
309114cephalexin 500 MG Oral CapsulePSN6440351e-065f-59da-e053-2a91aa0aa4c55
309114cephalexin 500 MG Oral CapsuleSCD6440351e-065f-59da-e053-2a91aa0aa4c55
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6440351e-065f-59da-e053-2a91aa0aa4c55
309114cephalexin 500 MG Oral CapsulePSN6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e4
309114cephalexin 500 MG Oral CapsuleSCD6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e4
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e4
309114cephalexin 500 MG Oral CapsulePSNb9055316-6bda-434c-9620-046cd4623db33
309114cephalexin 500 MG Oral CapsulePSN86fe2a70-3e02-4d43-8d96-d47d4895388a3
309114cephalexin 500 MG Oral CapsulePSNffead704-cd5f-489f-bf32-108a42b476063
309114cephalexin 500 MG Oral CapsuleSCD86fe2a70-3e02-4d43-8d96-d47d4895388a3
309114cephalexin 500 MG Oral CapsuleSCDb9055316-6bda-434c-9620-046cd4623db33
309114cephalexin 500 MG Oral CapsuleSCDffead704-cd5f-489f-bf32-108a42b476063
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY86fe2a70-3e02-4d43-8d96-d47d4895388a3
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYb9055316-6bda-434c-9620-046cd4623db33
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYffead704-cd5f-489f-bf32-108a42b476063
309114cephalexin 500 MG Oral CapsulePSN8be6abb0-5ffa-499d-90d6-3c094cdf273e2
309114cephalexin 500 MG Oral CapsulePSN13444dc7-7da1-4181-a9ac-d95d4a235e6d2
309114cephalexin 500 MG Oral CapsulePSN278c84f7-530c-45d5-bdcb-78a3cc1a37002
309114cephalexin 500 MG Oral CapsulePSNb8136dc3-3942-4c72-a18c-00a6d823887d2
309114cephalexin 500 MG Oral CapsuleSCD8be6abb0-5ffa-499d-90d6-3c094cdf273e2
309114cephalexin 500 MG Oral CapsuleSCD278c84f7-530c-45d5-bdcb-78a3cc1a37002
309114cephalexin 500 MG Oral CapsuleSCDb8136dc3-3942-4c72-a18c-00a6d823887d2
309114cephalexin 500 MG Oral CapsuleSCD13444dc7-7da1-4181-a9ac-d95d4a235e6d2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSYb8136dc3-3942-4c72-a18c-00a6d823887d2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY8be6abb0-5ffa-499d-90d6-3c094cdf273e2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY13444dc7-7da1-4181-a9ac-d95d4a235e6d2
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY278c84f7-530c-45d5-bdcb-78a3cc1a37002
309112cephalexin 250 MG Oral CapsulePSN6032b68f-16d8-41b6-bd2c-86d5406a757a1
309114cephalexin 500 MG Oral CapsulePSN508a3401-df0b-0555-e063-6294a90a155a1
309114cephalexin 500 MG Oral CapsulePSN21ddeb9e-60ed-1c66-e063-6394a90a3eb51
309114cephalexin 500 MG Oral CapsulePSN6032b68f-16d8-41b6-bd2c-86d5406a757a1
309112cephalexin 250 MG Oral CapsuleSCD6032b68f-16d8-41b6-bd2c-86d5406a757a1
309114cephalexin 500 MG Oral CapsuleSCD508a3401-df0b-0555-e063-6294a90a155a1
309114cephalexin 500 MG Oral CapsuleSCD6032b68f-16d8-41b6-bd2c-86d5406a757a1
309114cephalexin 500 MG Oral CapsuleSCD21ddeb9e-60ed-1c66-e063-6394a90a3eb51
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY508a3401-df0b-0555-e063-6294a90a155a1
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY21ddeb9e-60ed-1c66-e063-6394a90a3eb51
309114cefalexin (as cefalexin monohydrate) 500 MG Oral CapsuleSY6032b68f-16d8-41b6-bd2c-86d5406a757a1
309112cephalexin (as cephalexin monohydrate) 250 MG Oral CapsuleSY6032b68f-16d8-41b6-bd2c-86d5406a757a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-122-0168180012201100 CAPSULE in 1 BOTTLE (68180-122-01) 100 capsule2006-11-010000-00-00NoNoCurrent
68180-122-0268180012202500 CAPSULE in 1 BOTTLE (68180-122-02) 500 capsule2006-11-010000-00-00NoNoCurrent