Cefdinir

Product NDC: 68180-723
Requested package NDC: 68180-723-20
11-digit product format: 681800723
Labeler code: 68180
Product ID: 68180-723_b32b7bfb-4770-4da0-8c48-684233cd10c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA065259
Marketing category: ANDA
Marketing start: 2007-05-07
Substance: CEFDINIR
Active strength: 250 mg/5mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68180-723	68180-723-20	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A065259-001	CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2006-05-31
A065259-002	CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065259-001	AB
A065259-002	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	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065259-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2006-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065259-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-07	`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	A065259-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065259-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065259-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065259-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065259-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065259-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065259-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065259-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065259-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065259-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065259-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065259-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065259-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065259-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065259-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065259-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065259-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065259-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065259-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065259-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065259-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065259-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065259-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065259-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065259-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065259-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065259-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065259-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065259-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065259-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065259-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065259-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065259-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065259-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065259-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065259-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065259-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065259-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065259-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065259-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFDINIR	250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CI0FAO63WC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309054	Internal RxNorm lookup
476576	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
7490df67-56c0-4a1c-8533-2107f3e8aea5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
d3e72f63-2c41-955f-f4ce-e90c6403e67c	Product name	2	20210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1	Product name	2	20210729
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
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68180-723-04	Cefdinir	60 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	60	9
68180-723-05	Cefdinir	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	9
68180-723-10	Cefdinir	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	9
68180-723-20	Cefdinir	60 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	60	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-723-04	ML - Milliliter	68180-723	1172b959-611a-4ea5-9252-0eff149dea6b	1	2020-07-13
68180-723-05	ML - Milliliter	68180-723	67b0c16d-a74f-4d56-b743-7f2ba607dea4	1	2020-07-13
68180-723-10	ML - Milliliter	68180-723	930a24c2-9387-456e-8134-1be8427bf2a4	1	2012-07-24
68180-723-20	ML - Milliliter	68180-723	cd52e6af-139b-4dd7-97b4-c9db56878ab9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEFDINIR POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	1
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
CITRIC ACID	INACTIVE INGREDIENT	2968PHW8QP	CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	1
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEFDINIR (CEFDINIR) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEFDINIR POWDER, FOR SUSPENSION [DISPENSING SOLUTIONS, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEFDINIR POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-723	CEFDINIR POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 4 package rows	20250130_7490df67-56c0-4a1c-8533-2107f3e8aea5.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	3714d558-cbaa-42e8-831b-ffbbc951ebf2	2026-04-21	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	A-S Medication Solutions	17b4e82f-4169-4ab9-bd4a-79781a71e160	2025-12-19	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	Lupin Pharmaceuticals, Inc.	7490df67-56c0-4a1c-8533-2107f3e8aea5	2025-09-23	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259 ndc (package): 68180-723-20 ndc (product): 68180-723 ndc11 (package): 68180072320
Cefdinir	CEFDINIR	Asclemed USA, Inc.	e90660c8-2714-4592-aeaa-bc9ceb26057c	2025-04-19	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	NuCare Pharmaceuticals, Inc.	2fb43fbe-2c4b-1df9-e063-6394a90a9913	2025-03-06	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	fbd76f8c-e6b8-52f4-e053-6394a90aa7ab	2025-02-04	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
CEFDINIR	CEFDINIR	DIRECT RX	982d0f53-20bc-1cb4-e053-2995a90ad33c	2025-01-22	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	1bbd75ea-5a50-eb00-e063-6394a90a1cec	2024-06-25	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	A-S Medication Solutions	37b5d000-db9e-4b6e-8208-6361e98fb55d	2023-11-01	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259
Cefdinir	CEFDINIR	Proficient Rx LP	444cd2c4-836d-40d5-a307-d719fe83e763	2022-05-02	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CI0FAO63WC	CEFDINIR	91832-40-5	CEFDINIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	17b4e82f-4169-4ab9-bd4a-79781a71e160	16
476576	cefdinir 50 MG/ML Oral Suspension	SCD	17b4e82f-4169-4ab9-bd4a-79781a71e160	16
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	17b4e82f-4169-4ab9-bd4a-79781a71e160	16
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	7490df67-56c0-4a1c-8533-2107f3e8aea5	9
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	7490df67-56c0-4a1c-8533-2107f3e8aea5	9
309054	cefdinir 25 MG/ML Oral Suspension	SCD	7490df67-56c0-4a1c-8533-2107f3e8aea5	9
476576	cefdinir 50 MG/ML Oral Suspension	SCD	7490df67-56c0-4a1c-8533-2107f3e8aea5	9
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	7490df67-56c0-4a1c-8533-2107f3e8aea5	9
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	7490df67-56c0-4a1c-8533-2107f3e8aea5	9
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
309054	cefdinir 25 MG/ML Oral Suspension	SCD	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
476576	cefdinir 50 MG/ML Oral Suspension	SCD	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	37b5d000-db9e-4b6e-8208-6361e98fb55d	3
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	3bf75b93-b42d-44f2-8cce-70ad3ca77cd5	3
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	444cd2c4-836d-40d5-a307-d719fe83e763	3
476576	cefdinir 50 MG/ML Oral Suspension	SCD	3bf75b93-b42d-44f2-8cce-70ad3ca77cd5	3
476576	cefdinir 50 MG/ML Oral Suspension	SCD	444cd2c4-836d-40d5-a307-d719fe83e763	3
476576	cefdinir 50 MG/ML Oral Suspension	SCD	37b5d000-db9e-4b6e-8208-6361e98fb55d	3
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	3bf75b93-b42d-44f2-8cce-70ad3ca77cd5	3
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	444cd2c4-836d-40d5-a307-d719fe83e763	3
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	37b5d000-db9e-4b6e-8208-6361e98fb55d	3
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	fbd76f8c-e6b8-52f4-e053-6394a90aa7ab	2
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	8640931e-317a-42b4-806a-146f00ddf2a6	2
476576	cefdinir 50 MG/ML Oral Suspension	SCD	8640931e-317a-42b4-806a-146f00ddf2a6	2
476576	cefdinir 50 MG/ML Oral Suspension	SCD	fbd76f8c-e6b8-52f4-e053-6394a90aa7ab	2
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	8640931e-317a-42b4-806a-146f00ddf2a6	2
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	fbd76f8c-e6b8-52f4-e053-6394a90aa7ab	2
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	e90660c8-2714-4592-aeaa-bc9ceb26057c	1
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	2c3705f2-0b44-4d38-a7f9-4b392d0a1a45	1
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	a4587ea9-c06b-4603-beea-1ef926a4d0be	1
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	e90660c8-2714-4592-aeaa-bc9ceb26057c	1
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	3714d558-cbaa-42e8-831b-ffbbc951ebf2	1
309054	cefdinir 25 MG/ML Oral Suspension	SCD	e90660c8-2714-4592-aeaa-bc9ceb26057c	1
476576	cefdinir 50 MG/ML Oral Suspension	SCD	3714d558-cbaa-42e8-831b-ffbbc951ebf2	1
476576	cefdinir 50 MG/ML Oral Suspension	SCD	a4587ea9-c06b-4603-beea-1ef926a4d0be	1
476576	cefdinir 50 MG/ML Oral Suspension	SCD	e90660c8-2714-4592-aeaa-bc9ceb26057c	1
476576	cefdinir 50 MG/ML Oral Suspension	SCD	2c3705f2-0b44-4d38-a7f9-4b392d0a1a45	1
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	e90660c8-2714-4592-aeaa-bc9ceb26057c	1
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	2c3705f2-0b44-4d38-a7f9-4b392d0a1a45	1
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	a4587ea9-c06b-4603-beea-1ef926a4d0be	1
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	e90660c8-2714-4592-aeaa-bc9ceb26057c	1
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	3714d558-cbaa-42e8-831b-ffbbc951ebf2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-723-20	68180072320	60 mL in 1 BOTTLE (68180-723-20)	60 ml	2007-05-07	2022-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir for Oral Suspension USP	Preferred Pharmaceuticals Inc.	2026-04-21	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir for Oral Suspension USP	A-S Medication Solutions	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	16
Cefdinir for Oral Suspension USP	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-09-23	HUMAN PRESCRIPTION DRUG LABEL	9
Cefdinir for Oral Suspension USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-04-19	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir for Oral Suspension USP	NuCare Pharmaceuticals,Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	2
CEFDINIR	DIRECT RX	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	8
Cefdinir for Oral Suspension USP	A-S Medication Solutions	2023-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir for Oral Suspension USP	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir for Oral Suspension USP	Preferred Pharmaceuticals, Inc.	2021-04-06	HUMAN PRESCRIPTION DRUG LABEL	4
Cefdinir for Oral Suspension USP	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir for Oral Suspension USP	Aidarex Pharmaceuticals LLC	2012-09-12	HUMAN PRESCRIPTION DRUG LABEL	2
Cefdinir for Oral Suspension USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-02-14	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir for Oral Suspension USP	Rebel Distributors Corp	2012-02-09	HUMAN PRESCRIPTION DRUG LABEL	1