Cefdinir

Product NDC: 65862-218
11-digit product format: 658620218
Labeler code: 65862
Product ID: 65862-218_9cfbe4a1-045c-489f-8ca7-9d595997dab7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065473
Marketing category: ANDA
Marketing start: 2007-12-14
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
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	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
06fbdb63-d32f-4212-9962-f1de15597dda	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	SPL version
65862-218-01	Cefdinir	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	13
65862-218-01	Cefdinir	1 in 1 CARTON	POWDER, FOR SUSPENSION	1	13
65862-218-60	Cefdinir	1 in 1 CARTON	POWDER, FOR SUSPENSION	1	13
65862-218-60	Cefdinir	60 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	60	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-218-01	ML - Milliliter	65862-218	bee220d9-acde-45d7-a2da-8af4c8423524	1	2012-07-24
65862-218-60	ML - Milliliter	65862-218	6bf3851b-f1bc-4eab-be9d-5c947b38734f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	7
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	7
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	7
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	7
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	7
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	7
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	7
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	7
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEFDINIR POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-218	CEFDINIR POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	13	Current NDC, Legacy NDC, 4 package rows	20240216_06fbdb63-d32f-4212-9962-f1de15597dda.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
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 ndc (product): 65862-218
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
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	06fbdb63-d32f-4212-9962-f1de15597dda	13
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	06fbdb63-d32f-4212-9962-f1de15597dda	13
309054	cefdinir 25 MG/ML Oral Suspension	SCD	06fbdb63-d32f-4212-9962-f1de15597dda	13
476576	cefdinir 50 MG/ML Oral Suspension	SCD	06fbdb63-d32f-4212-9962-f1de15597dda	13
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	06fbdb63-d32f-4212-9962-f1de15597dda	13
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	06fbdb63-d32f-4212-9962-f1de15597dda	13
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	fb02aaab-d2a0-466e-8327-72e3df1e4e9d	9
309054	cefdinir 25 MG/ML Oral Suspension	SCD	fb02aaab-d2a0-466e-8327-72e3df1e4e9d	9
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	fb02aaab-d2a0-466e-8327-72e3df1e4e9d	9
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
309054	cefdinir 25 MG/ML Oral Suspension	SCD	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
476576	cefdinir 50 MG/ML Oral Suspension	SCD	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	982d0f53-20bc-1cb4-e053-2995a90ad33c	8
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	be963e80-e298-49a0-a52f-3d4dcded7c8c	5
309054	cefdinir 25 MG/ML Oral Suspension	SCD	be963e80-e298-49a0-a52f-3d4dcded7c8c	5
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	be963e80-e298-49a0-a52f-3d4dcded7c8c	5
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	8dfbad95-4dd8-01fd-e053-2a95a90a1de1	3
309054	cefdinir 25 MG/ML Oral Suspension	SCD	8dfbad95-4dd8-01fd-e053-2a95a90a1de1	3
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	8dfbad95-4dd8-01fd-e053-2a95a90a1de1	3
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	3ab60dc3-c39c-4580-b418-1251a1b99c73	2
309054	cefdinir 25 MG/ML Oral Suspension	SCD	3ab60dc3-c39c-4580-b418-1251a1b99c73	2
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	3ab60dc3-c39c-4580-b418-1251a1b99c73	2
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	d9243be5-bd27-4f37-ba8b-9f6f55f8b3e4	1
309054	cefdinir 125 MG in 5 mL Oral Suspension	PSN	ee56347c-b61e-4648-ab88-d3af36f7dc8b	1
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	d9243be5-bd27-4f37-ba8b-9f6f55f8b3e4	1
309054	cefdinir 25 MG/ML Oral Suspension	SCD	ee56347c-b61e-4648-ab88-d3af36f7dc8b	1
309054	cefdinir 25 MG/ML Oral Suspension	SCD	d9243be5-bd27-4f37-ba8b-9f6f55f8b3e4	1
476576	cefdinir 50 MG/ML Oral Suspension	SCD	d9243be5-bd27-4f37-ba8b-9f6f55f8b3e4	1
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	d9243be5-bd27-4f37-ba8b-9f6f55f8b3e4	1
309054	cefdinir 125 MG per 5 ML Oral Suspension	SY	ee56347c-b61e-4648-ab88-d3af36f7dc8b	1
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	d9243be5-bd27-4f37-ba8b-9f6f55f8b3e4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-218-01	65862021801	1 BOTTLE in 1 CARTON (65862-218-01) / 100 mL in 1 BOTTLE	1 bottle	2007-12-14	0000-00-00	No	No	Current
65862-218-60	65862021860	1 BOTTLE in 1 CARTON (65862-218-60) / 60 mL in 1 BOTTLE	1 bottle	2007-12-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEFDINIR	DIRECT RX	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	8
Cefdinir for Oral Suspension, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir for Oral Suspension, USP Rx only	Aurobindo Pharma Limited	2024-02-14	Human Prescription Drug Label	13
Cefdinir for Oral Suspension, USP Rx only	Preferred Pharmaceuticals Inc.	2023-04-12	HUMAN PRESCRIPTION DRUG LABEL	4
Cefdinir for Oral Suspension, USP Rx only	A-S Medication Solutions	2023-04-04	Human Prescription Drug Label	9
Cefdinir for Oral Suspension, USP Rx only	RPK Pharmaceuticals, Inc.	2023-01-31	Human Prescription Drug Label	2
CEFDINIR FOR ORAL SUSPENSION, USP Rx Only	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	5
Cefdinir for Oral Suspension, USP Rx only	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	2
CEFDINIR FOR ORAL SUSPENSION, USP Rx Only	Aidarex Pharmaceuticals LLC	2017-05-18	HUMAN PRESCRIPTION DRUG LABEL	1
CEFDINIR FOR ORAL SUSPENSION	Physicians Total Care, Inc.	2009-12-16	Human Prescription Drug Label	1