CEFPROZIL

Product NDC: 68180-401
11-digit product format: 681800401
Labeler code: 68180
Product ID: 68180-401_45d1a412-407b-48d4-be64-b9c7ec3c5205
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEFPROZIL
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA065261
Marketing category: ANDA
Marketing start: 2005-12-01
Substance: CEFPROZIL
Active strength: 125 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68180-401	68180-401-01	D	Discontinued by firm		2026-08-17
excluded package	package	68180-401	68180-401-02	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	68180-401-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	68180-401-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	68180-401-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	68180-401-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	68180-401-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	68180-401-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	68180-401-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	68180-401-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	68180-401-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	68180-401-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	68180-401-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	68180-401-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	68180-401-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	68180-401-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	68180-401-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	68180-401-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	68180-401-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	68180-401-02	`0efc9e666f02…`	`f202fb6c5f17…`

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
A065261-001	CEFPROZIL	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19
A065261-002	CEFPROZIL	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065261-001	AB
A065261-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065261-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2005-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065261-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2005-12-19	`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	A065261-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065261-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065261-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065261-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065261-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065261-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065261-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065261-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065261-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065261-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065261-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065261-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065261-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065261-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065261-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065261-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065261-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065261-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065261-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065261-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065261-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065261-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065261-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065261-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065261-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065261-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065261-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065261-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065261-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065261-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065261-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065261-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065261-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065261-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065261-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065261-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065261-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065261-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065261-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065261-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4W0459ZA4V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309080	Internal RxNorm lookup
309081	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
3ec55c0a-1456-412e-972f-352b3135c8f2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
228ef569-e7f1-4dcf-b820-c09522f86f2e	Product name	1	20250129
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68180-401-01	CEFPROZIL	50 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	50	9
68180-401-02	CEFPROZIL	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75	9
68180-401-03	CEFPROZIL	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-401-01	ML - Milliliter	68180-401	0d771896-8e7b-47cd-aee5-fee0439f6523	1	2012-07-24
68180-401-02	ML - Milliliter	68180-401	82c3dcf7-602a-4ce8-9e54-78f9a595d2aa	1	2012-07-24
68180-401-03	ML - Milliliter	68180-401	4afaad0f-f43d-4102-8759-9de0b0f29a87	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFPROZIL	ACTIVE INGREDIENT	4W0459ZA4V	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
CEFPROZIL	ACTIVE MOIETY	4W0459ZA4V	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-401	CEFPROZIL POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 3 package rows	20250130_3ec55c0a-1456-412e-972f-352b3135c8f2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFPROZIL	CEFPROZIL	Lupin Pharmaceuticals, Inc.	800a2ec0-4798-4423-9613-d03024cf1f0e	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065261 application number: ANDA065261
CEFPROZIL	CEFPROZIL	Lupin Pharmaceuticals, Inc.	3ec55c0a-1456-412e-972f-352b3135c8f2	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065261 application number: ANDA065261 ndc (product): 68180-401

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4W0459ZA4V	CEFPROZIL	121123-17-9	CEFPROZIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309080	cefprozil 125 MG in 5 mL Oral Suspension	PSN	3ec55c0a-1456-412e-972f-352b3135c8f2	9
309081	cefprozil 250 MG in 5 mL Oral Suspension	PSN	3ec55c0a-1456-412e-972f-352b3135c8f2	9
309080	cefprozil 25 MG/ML Oral Suspension	SCD	3ec55c0a-1456-412e-972f-352b3135c8f2	9
309081	cefprozil 50 MG/ML Oral Suspension	SCD	3ec55c0a-1456-412e-972f-352b3135c8f2	9
309080	cefprozil 125 MG per 5 ML Oral Suspension	SY	3ec55c0a-1456-412e-972f-352b3135c8f2	9
309081	cefprozil 250 MG per 5 ML Oral Suspension	SY	3ec55c0a-1456-412e-972f-352b3135c8f2	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-401-01	68180040101	50 mL in 1 BOTTLE (68180-401-01)	50 ml	2005-12-01	0000-00-00	No	No	Current
68180-401-02	68180040102	75 mL in 1 BOTTLE (68180-401-02)	75 ml	2005-12-01	0000-00-00	No	No	Current
68180-401-03	68180040103	100 mL in 1 BOTTLE (68180-401-03)	100 ml	2005-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFPROZIL FOR ORAL SUSPENSION USP 125 mg/5 mL and 250 mg/5 mL Rx Only	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-10-10	HUMAN PRESCRIPTION DRUG LABEL	9