Cefdinir

Product NDC
0093-4136
11-digit product format
000934136
Labeler code
0093
Product ID
0093-4136_7f269e55-b085-4315-807a-e425f0189b2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefdinir
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065332
Marketing category
ANDA
Marketing start
2007-05-08
Substance
CEFDINIR MONOHYDRATE
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065332-001CEFDINIRCEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-04
A065332-002CEFDINIRCEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065332-001AB
A065332-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065332-001CEFDINIR125MG/5MLFOR SUSPENSION / ORALAB2007-05-04782e0a99824c…
2021-12-28 21:50 UTC2021-12A065332-002CEFDINIR250MG/5MLFOR SUSPENSION / ORALAB2007-05-04782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065332-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065332-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065332-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065332-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065332-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065332-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065332-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065332-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065332-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065332-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065332-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065332-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065332-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065332-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065332-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065332-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065332-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065332-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065332-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065332-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065332-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065332-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065332-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065332-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065332-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065332-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065332-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065332-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065332-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065332-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065332-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065332-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065332-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065332-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065332-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065332-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065332-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065332-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065332-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065332-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Cefdinir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFDINIR MONOHYDRATE125 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6E7SN358SEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309054Internal RxNorm lookup
476576Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a1f49fe1-b511-4f6b-a912-8ae8662d95a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
d3e72f63-2c41-955f-f4ce-e90c6403e67cProduct name220210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1Product name220210729
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-4136-64Cefdinir60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION6015
0093-4136-73Cefdinir100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-4136-64ML - Milliliter0093-4136852b3ef8-9e22-480d-87e5-8a9b1ab3076612012-07-24
0093-4136-73ML - Milliliter0093-41368621fbc6-f208-4753-a1c5-78cee429c3aa12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-4136CEFDINIR POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20240305_a1f49fe1-b511-4f6b-a912-8ae8662d95a5.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefdinirCEFDINIRPreferred Pharmaceuticals Inc.0d1212c9-604f-4999-8f7d-e7cf300705ef2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065332
application number: ANDA065332
CefdinirCEFDINIRA-S Medication Solutions1d58b10c-b253-4925-8681-580aa2e8ae2e2025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065332
application number: ANDA065332
CefdinirCEFDINIRNuCare Pharmaceuticals, Inc.4ade94bb-6c39-13cd-e054-00144ff8d46c2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065332
application number: ANDA065332
CefdinirCEFDINIRTeva Pharmaceuticals USA, Inc.a1f49fe1-b511-4f6b-a912-8ae8662d95a52023-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065332
application number: ANDA065332
ndc (product): 0093-4136
CefdinirCEFDINIRProficient Rx LPf22acd90-5dc4-406d-af78-5f9c3a6746472022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065332
application number: ANDA065332

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNa1f49fe1-b511-4f6b-a912-8ae8662d95a515
476576cefdinir 250 MG in 5 mL Oral SuspensionPSNa1f49fe1-b511-4f6b-a912-8ae8662d95a515
309054cefdinir 25 MG/ML Oral SuspensionSCDa1f49fe1-b511-4f6b-a912-8ae8662d95a515
476576cefdinir 50 MG/ML Oral SuspensionSCDa1f49fe1-b511-4f6b-a912-8ae8662d95a515
309054cefdinir 125 MG per 5 ML Oral SuspensionSYa1f49fe1-b511-4f6b-a912-8ae8662d95a515
476576cefdinir 250 MG per 5 ML Oral SuspensionSYa1f49fe1-b511-4f6b-a912-8ae8662d95a515
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN1d58b10c-b253-4925-8681-580aa2e8ae2e12
309054cefdinir 25 MG/ML Oral SuspensionSCD1d58b10c-b253-4925-8681-580aa2e8ae2e12
309054cefdinir 125 MG per 5 ML Oral SuspensionSY1d58b10c-b253-4925-8681-580aa2e8ae2e12
309054cefdinir 125 MG in 5 mL Oral SuspensionPSN4ade94bb-6c39-13cd-e054-00144ff8d46c6
309054cefdinir 25 MG/ML Oral SuspensionSCD4ade94bb-6c39-13cd-e054-00144ff8d46c6
309054cefdinir 125 MG per 5 ML Oral SuspensionSY4ade94bb-6c39-13cd-e054-00144ff8d46c6
309054cefdinir 125 MG in 5 mL Oral SuspensionPSNc335ee41-a4fe-43c9-bf21-91b24992378c3
309054cefdinir 25 MG/ML Oral SuspensionSCDc335ee41-a4fe-43c9-bf21-91b24992378c3
309054cefdinir 125 MG per 5 ML Oral SuspensionSYc335ee41-a4fe-43c9-bf21-91b24992378c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-4136-640009341366460 mL in 1 BOTTLE (0093-4136-64) 60 ml2007-05-080000-00-00NoNoCurrent
0093-4136-7300093413673100 mL in 1 BOTTLE (0093-4136-73) 100 ml2007-05-080000-00-00NoNoCurrent