Cefdinir

Product NDC: 63187-616
11-digit product format: 631870616
Labeler code: 63187
Product ID: 63187-616_aec22cad-186d-4dac-9fe3-c3b4d6075b2c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Proficient Rx LP
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: 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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065332-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065332-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-05-04	`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	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…`
2022-03-09 01:35 UTC	2022-03	A065332-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065332-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065332-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065332-002	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 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
f22acd90-5dc4-406d-af78-5f9c3a674647	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d3e72f63-2c41-955f-f4ce-e90c6403e67c	Product name	2	20210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1	Product name	2	20210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63187-616-00	Cefdinir	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		4
63187-616-60	Cefdinir	60 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-616-00	ML - Milliliter	63187-616	d5691816-5c48-44ff-a0da-b77c4aebc384	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-616	CEFDINIR POWDER, FOR SUSPENSION [PROFICIENT RX LP]	4	Current NDC, Legacy NDC, 2 package rows	20220402_f22acd90-5dc4-406d-af78-5f9c3a674647.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 63187-616

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

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	f22acd90-5dc4-406d-af78-5f9c3a674647	4
476576	cefdinir 50 MG/ML Oral Suspension	SCD	f22acd90-5dc4-406d-af78-5f9c3a674647	4
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	f22acd90-5dc4-406d-af78-5f9c3a674647	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-616-00	63187061600	100 mL in 1 BOTTLE (63187-616-00)	100 ml	2007-05-08	0000-00-00	No	No	Current
63187-616-60	63187061660	60 mL in 1 BOTTLE (63187-616-60)	60 ml	2007-05-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFDINIR FOR ORAL SUSPENSION USP 4136 4137 Rx only	Proficient Rx LP	2022-03-01	HUMAN PRESCRIPTION DRUG LABEL	4