cefdinir

Product NDC: 67877-547
11-digit product format: 678770547
Labeler code: 67877
Product ID: 67877-547_662007e2-462e-4513-b5b0-efd5dcdc2421
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cefdinir
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA210534
Marketing category: ANDA
Marketing start: 2021-02-20
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
A210534-001	CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2021-02-19
A210534-002	CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2021-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210534-001	AB
A210534-002	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 2 · 68 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	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A210534-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210534-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210534-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210534-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210534-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210534-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210534-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210534-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210534-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210534-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210534-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210534-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210534-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210534-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210534-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210534-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-002	AB	1	`87673890dc5c…`

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
efb5a975-75ec-46e1-ba84-f68d0b9bf36f	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	Strength	SPL version
67877-547-88	cefdinir	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		6
67877-547-98	cefdinir	60 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	60		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-547-88	ML - Milliliter	67877-547	6549f19e-9f14-46bf-bf22-41c3155e26d2	1	2021-04-08
67877-547-98	ML - Milliliter	67877-547	1caa8866-c6d1-42c2-838f-141271ec6dbf	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-547	CEFDINIR POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20220702_efb5a975-75ec-46e1-ba84-f68d0b9bf36f.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.	2e384d98-642e-4841-9f62-fcea4c242f4e	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534
cefdinir	CEFDINIR	A-S Medication Solutions	2bd2101c-511d-45a9-b1d8-a45ed40c5b80	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534
CEFDINIR	CEFDINIR	DIRECT RX	982d0f53-20bc-1cb4-e053-2995a90ad33c	2025-01-22	Warnings	Exact identifier application applno (ANDA): 210534 application number: ANDA210534
cefdinir	CEFDINIR	A-S Medication Solutions	7bbcc4ac-c964-4c6b-88c0-11c0ba9933db	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534
cefdinir	CEFDINIR	Ascend Laboratories, LLC	efb5a975-75ec-46e1-ba84-f68d0b9bf36f	2022-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534 ndc (product): 67877-547

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	2bd2101c-511d-45a9-b1d8-a45ed40c5b80	8
309054	cefdinir 25 MG/ML Oral Suspension	SCD	2bd2101c-511d-45a9-b1d8-a45ed40c5b80	8
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	2bd2101c-511d-45a9-b1d8-a45ed40c5b80	8
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	2e384d98-642e-4841-9f62-fcea4c242f4e	7
309054	cefdinir 25 MG/ML Oral Suspension	SCD	2e384d98-642e-4841-9f62-fcea4c242f4e	7
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	2e384d98-642e-4841-9f62-fcea4c242f4e	7
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	efb5a975-75ec-46e1-ba84-f68d0b9bf36f	6
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	efb5a975-75ec-46e1-ba84-f68d0b9bf36f	6
309054	cefdinir 25 MG/ML Oral Suspension	SCD	efb5a975-75ec-46e1-ba84-f68d0b9bf36f	6
476576	cefdinir 50 MG/ML Oral Suspension	SCD	efb5a975-75ec-46e1-ba84-f68d0b9bf36f	6
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	efb5a975-75ec-46e1-ba84-f68d0b9bf36f	6
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	efb5a975-75ec-46e1-ba84-f68d0b9bf36f	6
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	c8c34c9a-baab-1f0f-e053-2a95a90a2635	2
309054	cefdinir 25 MG/ML Oral Suspension	SCD	c8c34c9a-baab-1f0f-e053-2a95a90a2635	2
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	c8c34c9a-baab-1f0f-e053-2a95a90a2635	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-547-88	67877054788	100 mL in 1 BOTTLE (67877-547-88)	100 ml	2021-02-20	0000-00-00	No	No	Current
67877-547-98	67877054798	60 mL in 1 BOTTLE (67877-547-98)	60 ml	2021-02-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir for Oral Suspension USP Rx only	Preferred Pharmaceuticals Inc.	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	7
Cefdinir for Oral Suspension USP Rx only	A-S Medication Solutions	2026-03-12	Human Prescription Drug Label	8
Cefdinir for Oral Suspension USP Rx only	NuCare Pharmaceuticals,Inc.	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	2
Cefdinir for Oral Suspension USP Rx only	NuCare Pharmaceuticals,Inc.	2022-10-06	HUMAN PRESCRIPTION DRUG LABEL	2
Cefdinir for Oral Suspension USP Rx only	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2022-06-29	Human Prescription Drug Label	6