Cefdinir

Product NDC: 76420-327
Requested package NDC: 76420-327-01
11-digit product format: 764200327
Labeler code: 76420
Product ID: 76420-327_331b63bf-fd36-155d-e063-6294a90aec23
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA065259
Marketing category: ANDA
Marketing start: 2006-05-31
Substance: CEFDINIR
Active strength: 125 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
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	125 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
e90660c8-2714-4592-aeaa-bc9ceb26057c	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
76420-327-01	Cefdinir	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		1
76420-327-60	Cefdinir	60 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-327	CEFDINIR POWDER, FOR SUSPENSION [ASCLEMED USA, INC.]	1	Current NDC, 2 package rows	20250424_e90660c8-2714-4592-aeaa-bc9ceb26057c.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
Cefdinir	CEFDINIR	Asclemed USA, Inc.	e90660c8-2714-4592-aeaa-bc9ceb26057c	2025-04-19	Warnings	Exact identifier application applno (ANDA): 065259 application number: ANDA065259 ndc (package): 76420-327-01 ndc (product): 76420-327 ndc11 (package): 76420032701
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
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	e90660c8-2714-4592-aeaa-bc9ceb26057c	1
309054	cefdinir 25 MG/ML Oral Suspension	SCD	e90660c8-2714-4592-aeaa-bc9ceb26057c	1
476576	cefdinir 50 MG/ML Oral Suspension	SCD	e90660c8-2714-4592-aeaa-bc9ceb26057c	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	e90660c8-2714-4592-aeaa-bc9ceb26057c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-327-01	76420032701	100 mL in 1 BOTTLE (76420-327-01)	100 ml	2025-04-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir for Oral Suspension USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-04-19	HUMAN PRESCRIPTION DRUG LABEL	1