Cefdinir

Product NDC: 68071-5106
11-digit product format: 680715106
Labeler code: 68071
Product ID: 68071-5106_1b46ce4d-fa1c-4ce1-e063-6394a90a15f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA065473
Marketing category: ANDA
Marketing start: 2007-12-14
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

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-5106-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-5106-6	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-5106-6	`1332a3947898…`	`d4bfe170f9cd…`

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
A065473-001	CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14
A065473-002	CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065473-001	AB
A065473-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	RS	2007-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065473-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065473-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-12-14	`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	A065473-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065473-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065473-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065473-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065473-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065473-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065473-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065473-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065473-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065473-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065473-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065473-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065473-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065473-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065473-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065473-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065473-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065473-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065473-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065473-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065473-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065473-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065473-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065473-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065473-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065473-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065473-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065473-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065473-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065473-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065473-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065473-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065473-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065473-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065473-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065473-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065473-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065473-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065473-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065473-002	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 · 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
96cad498-70d3-3089-e053-2995a90a9d19	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-19	Cefdinir for Oral Suspension, USP Rx only
2023-01-30	Cefdinir for Oral Suspension, USP Rx only
2021-02-22	Cefdinir for Oral Suspension, USP Rx only
2021-01-29	Cefdinir for Oral Suspension, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-5106-6	Cefdinir	60 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5106	CEFDINIR POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240621_96cad498-70d3-3089-e053-2995a90a9d19.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	5b6c1b5d-a1d5-4e08-9077-2af3f38fea4e	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473
CEFDINIR	CEFDINIR	DIRECT RX	982d0f53-20bc-1cb4-e053-2995a90ad33c	2025-01-22	Warnings	Exact identifier application applno (ANDA): 065473 application number: ANDA065473
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	96cad498-70d3-3089-e053-2995a90a9d19	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473 ndc (product): 68071-5106
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	8dfbad95-4dd8-01fd-e053-2a95a90a1de1	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473
Cefdinir	CEFDINIR	A-S Medication Solutions	beeb9480-f9f9-44ae-93f3-6f4da81888f5	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473
Cefdinir	CEFDINIR	Aurobindo Pharma Limited	06fbdb63-d32f-4212-9962-f1de15597dda	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473
Cefdinir	CEFDINIR	A-S Medication Solutions	fb02aaab-d2a0-466e-8327-72e3df1e4e9d	2023-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473
Cefdinir	CEFDINIR	Proficient Rx LP	be963e80-e298-49a0-a52f-3d4dcded7c8c	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473
Cefdinir	CEFDINIR	Proficient Rx LP	8305b5d8-53b3-475a-b263-07d5fd81392a	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065473 application number: ANDA065473

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	96cad498-70d3-3089-e053-2995a90a9d19	3
476576	cefdinir 50 MG/ML Oral Suspension	SCD	96cad498-70d3-3089-e053-2995a90a9d19	3
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	96cad498-70d3-3089-e053-2995a90a9d19	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5106-6	68071510606	60 mL in 1 BOTTLE (68071-5106-6)	60 ml	2019-11-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir for Oral Suspension, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	3