Cefdinir

Product NDC: 50090-3725
11-digit product format: 500903725
Labeler code: 50090
Product ID: 50090-3725_3cc63f9c-2bd7-41d6-a5cd-ceb9be0d6d7b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA065332
Marketing category: ANDA
Marketing start: 2007-05-08
Substance: CEFDINIR MONOHYDRATE
Active strength: 250 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 43.

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
A065332-001	CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-05-04
A065332-002	CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065332-001	AB
A065332-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065332-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065332-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065332-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065332-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065332-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065332-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065332-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065332-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065332-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065332-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065332-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065332-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065332-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065332-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065332-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065332-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065332-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065332-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065332-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065332-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065332-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065332-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065332-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065332-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065332-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065332-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065332-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065332-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065332-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065332-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065332-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065332-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065332-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065332-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065332-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065332-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065332-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065332-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065332-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065332-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6E7SN358SE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
0eeac6df-bad7-413e-8b41-0660f3a99373	Available on FDA.report

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
Cefdinir	CEFDINIR	A-S Medication Solutions	0eeac6df-bad7-413e-8b41-0660f3a99373	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065332 application number: ANDA065332 ndc (product): 50090-3725
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	0d1212c9-604f-4999-8f7d-e7cf300705ef	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065332 application number: ANDA065332
Cefdinir	CEFDINIR	A-S Medication Solutions	1d58b10c-b253-4925-8681-580aa2e8ae2e	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065332 application number: ANDA065332
Cefdinir	CEFDINIR	NuCare Pharmaceuticals, Inc.	4ade94bb-6c39-13cd-e054-00144ff8d46c	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065332 application number: ANDA065332
Cefdinir	CEFDINIR	Teva Pharmaceuticals USA, Inc.	a1f49fe1-b511-4f6b-a912-8ae8662d95a5	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065332 application number: ANDA065332
Cefdinir	CEFDINIR	Proficient Rx LP	f22acd90-5dc4-406d-af78-5f9c3a674647	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065332 application number: ANDA065332

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6E7SN358SE	CEFDINIR MONOHYDRATE	213978-34-8	CEFDINIR MONOHYDRATE
CI0FAO63WC	CEFDINIR	91832-40-5	Cefdinir

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-3725-0	50090372500	60 mL in 1 BOTTLE (50090-3725-0)	60 ml	2018-10-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir for Oral Suspension, USP Rx only	A-S Medication Solutions	2026-08-20	HUMAN PRESCRIPTION DRUG LABEL	6