cephalexin

Product NDC: 68180-440
11-digit product format: 681800440
Labeler code: 68180
Product ID: 68180-440_78aee1aa-f859-489e-98b5-78af55b92374
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: FOR SUSPENSION
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA065234
Marketing category: ANDA
Marketing start: 2017-08-21
Substance: CEPHALEXIN
Active strength: 125 mg/5mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065234-001	CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2005-08-17
A065234-002	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2005-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065234-001	AB
A065234-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065234-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065234-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065234-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065234-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065234-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065234-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065234-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065234-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065234-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065234-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065234-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065234-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065234-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065234-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065234-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065234-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065234-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065234-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEPHALEXIN	125 mg/5mL

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
309110	Internal RxNorm lookup
309113	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
25ef498a-7a7e-4543-a544-b9d0e99f9cd9	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
64bb7f1a-2c2e-4741-8301-dbfeda7239f6	Product name	1	20190628
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
68180-440-01	cephalexin	100 mL in 1 BOTTLE	FOR SUSPENSION	100		13
68180-440-02	cephalexin	200 mL in 1 BOTTLE	FOR SUSPENSION	200		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-440-01	ML - Milliliter	68180-440	857099ad-4939-45ad-9efd-a471ed0754aa	1	2017-10-13
68180-440-02	ML - Milliliter	68180-440	16dfcdb8-7297-4016-9db0-e088bca2d6de	1	2017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-440	CEPHALEXIN FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240817_25ef498a-7a7e-4543-a544-b9d0e99f9cd9.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cephalexin	CEPHALEXIN	Lupin Pharmaceuticals, Inc.	25ef498a-7a7e-4543-a544-b9d0e99f9cd9	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234 ndc (product): 68180-440
cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	553485f8-890d-4929-a6bb-905221cf411d	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	141bd050-5dfc-68fa-e063-6394a90a6d86	2024-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	A-S Medication Solutions	d31da5be-c939-4aa0-adb8-b26a1396b228	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	Proficient Rx LP	829244bd-93da-4a5a-a257-890cfec4c06d	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	A-S Medication Solutions	0a24b6e5-6f13-44b4-93f4-47c86945cad2	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-440-01	68180044001	100 mL in 1 BOTTLE (68180-440-01)	100 ml	2017-08-21	0000-00-00	No	No	Current
68180-440-02	68180044002	200 mL in 1 BOTTLE (68180-440-02)	200 ml	2017-09-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
cephalexin	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	14