Cephalexin

Product NDC: 68180-121
11-digit product format: 681800121
Labeler code: 68180
Product ID: 68180-121_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: 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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065229-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2005-11-25
A065229-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2005-11-25

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065229-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065229-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065229-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065229-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065229-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065229-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065229-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065229-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065229-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065229-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065229-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065229-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065229-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065229-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065229-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065229-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065229-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065229-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEPHALEXIN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OBN7UDS42Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309112	Internal RxNorm lookup
309114	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dfa3f520-409c-432e-b6d3-9250d468c772	Product name	1	20250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6	Product name	1	20190628
398aa563-bb78-fe0f-46a8-757c40ef28bf	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68180-121-01	Cephalexin	100 in 1 BOTTLE	CAPSULE	100		9
68180-121-02	Cephalexin	500 in 1 BOTTLE	CAPSULE	500		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-121-01	EA - Each	68180-121	9866e5fe-960d-4bfc-98b4-99ad81b01db9	1	2012-07-24
68180-121-02	EA - Each	68180-121	f04bbb56-419d-4f0e-91f6-08ae99c95947	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
FERRIC OXIDE BLACK	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [H.J. HARKINS COMPANY, INC.]	3
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-121	CEPHALEXIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20201230_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	b3bb8222-161e-4d9c-8e08-7e22ad65bf72	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	8499aa5a-49b1-4555-bd27-6177d92b261d	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Coupler LLC	508a3401-df0b-0555-e063-6294a90a155a	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Sportpharm LLC	3d5a2665-65da-4b10-9e23-39fc88145da1	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	13444dc7-7da1-4181-a9ac-d95d4a235e6d	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Lupin Pharmaceuticals, Inc.	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229 ndc (product): 68180-121
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af4abf8b-22cc-da58-e053-2a95a90aa766	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	a33280d4-7caf-f74b-e053-2a95a90a90c3	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc	945552cb-90e4-41fb-afe2-8ee8785e94da	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	20f8cc57-231c-4d36-a209-ff9e5735d65c	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	728c5212-dbd8-8df5-e053-2a91aa0a9579	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af10128f-021a-14b7-e053-2a95a90a4365	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	6032b68f-16d8-41b6-bd2c-86d5406a757a	2022-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Proficient Rx LP	dec3a1ef-1e85-4236-804b-e7a343d3a58f	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OBN7UDS42Y	CEPHALEXIN	23325-78-2	CEPHALEXIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309112	cephalexin 250 MG Oral Capsule	PSN	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309112	cephalexin 250 MG Oral Capsule	PSN	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309114	cephalexin 500 MG Oral Capsule	PSN	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309114	cephalexin 500 MG Oral Capsule	PSN	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309112	cephalexin 250 MG Oral Capsule	SCD	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309112	cephalexin 250 MG Oral Capsule	SCD	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309114	cephalexin 500 MG Oral Capsule	SCD	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309114	cephalexin 500 MG Oral Capsule	SCD	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	9
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	ec8f8062-a065-41d8-a2ad-97aa49bf1c27	9
309112	cephalexin 250 MG Oral Capsule	PSN	728c5212-dbd8-8df5-e053-2a91aa0a9579	4
309112	cephalexin 250 MG Oral Capsule	SCD	728c5212-dbd8-8df5-e053-2a91aa0a9579	4
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	728c5212-dbd8-8df5-e053-2a91aa0a9579	4
309112	cephalexin 250 MG Oral Capsule	PSN	c5f1a7f6-a5a4-48f1-9022-d6d402bfd349	3
309112	cephalexin 250 MG Oral Capsule	PSN	a33280d4-7caf-f74b-e053-2a95a90a90c3	3
309112	cephalexin 250 MG Oral Capsule	SCD	c5f1a7f6-a5a4-48f1-9022-d6d402bfd349	3
309112	cephalexin 250 MG Oral Capsule	SCD	a33280d4-7caf-f74b-e053-2a95a90a90c3	3
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	a33280d4-7caf-f74b-e053-2a95a90a90c3	3
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	c5f1a7f6-a5a4-48f1-9022-d6d402bfd349	3
309112	cephalexin 250 MG Oral Capsule	PSN	ebf9dd58-a494-45a9-9ed3-a89887817193	2
309112	cephalexin 250 MG Oral Capsule	PSN	36e8f074-067e-4485-9386-d52d7faed5ab	2
309112	cephalexin 250 MG Oral Capsule	SCD	36e8f074-067e-4485-9386-d52d7faed5ab	2
309112	cephalexin 250 MG Oral Capsule	SCD	ebf9dd58-a494-45a9-9ed3-a89887817193	2
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	ebf9dd58-a494-45a9-9ed3-a89887817193	2
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	36e8f074-067e-4485-9386-d52d7faed5ab	2
309112	cephalexin 250 MG Oral Capsule	PSN	6032b68f-16d8-41b6-bd2c-86d5406a757a	1
309114	cephalexin 500 MG Oral Capsule	PSN	6032b68f-16d8-41b6-bd2c-86d5406a757a	1
309112	cephalexin 250 MG Oral Capsule	SCD	6032b68f-16d8-41b6-bd2c-86d5406a757a	1
309114	cephalexin 500 MG Oral Capsule	SCD	6032b68f-16d8-41b6-bd2c-86d5406a757a	1
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	6032b68f-16d8-41b6-bd2c-86d5406a757a	1
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	6032b68f-16d8-41b6-bd2c-86d5406a757a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-121-01	68180012101	100 CAPSULE in 1 BOTTLE (68180-121-01)	100 capsule	2006-11-01	0000-00-00	No	No	Current
68180-121-02	68180012102	500 CAPSULE in 1 BOTTLE (68180-121-02)	500 capsule	2006-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cephalexin	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	9
Cephalexin	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3
Cephalexin	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	4
Cephalexin	REMEDYREPACK INC.	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	2
Cephalexin	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	9
Cephalexin	PharmPak, Inc.	2022-10-09	HUMAN PRESCRIPTION DRUG LABEL	2
Cephalexin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-09-21	HUMAN PRESCRIPTION DRUG LABEL	1
Cephalexin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2022-01-31	HUMAN PRESCRIPTION DRUG LABEL	5
Cephalexin	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	12
Cephalexin	Bryant Ranch Prepack	2019-08-17	HUMAN PRESCRIPTION DRUG LABEL	3
Cephalexin	A-S Medication Solutions	2018-04-18	HUMAN PRESCRIPTION DRUG LABEL	8
CEPHALEXIN CAPSULES USP	Blenheim Pharmacal, Inc.	2013-06-04	HUMAN PRESCRIPTION DRUG LABEL	2
CEPHALEXIN CAPSULES USP	TYA Pharmaceuticals	2012-09-17	HUMAN PRESCRIPTION DRUG LABEL	2
CEPHALEXIN CAPSULES USP	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	3