Penicillin V Potassium

Product NDC
42708-098
11-digit product format
427080098
Labeler code
42708
Product ID
42708-098_45b39807-139e-eda6-e063-6294a90a103c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QPharma Inc
Application
ANDA065435
Marketing category
ANDA
Marketing start
2008-04-29
Substance
PENICILLIN V POTASSIUM
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [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
A065435-001PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29
A065435-002PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065435-001AB
A065435-002AB

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 UTC2026-02A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABRS2008-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2008-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2008-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2008-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2008-04-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2008-04-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065435-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2008-04-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A065435-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2008-04-29782e0a99824c…

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 UTC2026-02A065435-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065435-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065435-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065435-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065435-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065435-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065435-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065435-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065435-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065435-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065435-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065435-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065435-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065435-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065435-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065435-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065435-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065435-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065435-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065435-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065435-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065435-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065435-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065435-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065435-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065435-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065435-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065435-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065435-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065435-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065435-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065435-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065435-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065435-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065435-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065435-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065435-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065435-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065435-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065435-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Penicillin V Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PENICILLIN V POTASSIUM500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
146T0TU1JBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834102Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c11af69-146f-47ed-b12a-7b201fec7e50Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-098-142021-03-15C16284748780-1ba0f9c33-43f8-a910-e053-dadaa90a0b85Penicillin V Potassium Tablets, USP Rx only
42708-098-142021-01-29C16284748780-1ba0f9c33-43f8-a910-e053-dadaa90a0b85Penicillin V Potassium Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-098-14Penicillin V Potassium14 in 1 BOTTLETABLET, FILM COATED145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-098PENICILLIN V POTASSIUM TABLET, FILM COATED [QPHARMA INC]4Current NDC, Legacy NDC, 1 package rows20241123_8c11af69-146f-47ed-b12a-7b201fec7e50.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 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.fba1ffe5-809a-495b-bf3e-f2099ac459f62026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.8f9fa2c8-4d25-48a8-9257-43c33d08e83a2026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.b5972712-f735-46ed-a94a-b84668bb6a822026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMRedpharm Drug546c367a-c786-8326-e063-6294a90ae76c2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMProficient Rx LPb8f797fb-979c-4eab-a3a6-ad4edcb9ff072026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMQPharma Inc8c11af69-146f-47ed-b12a-7b201fec7e502025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
ndc (product): 42708-098
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.9bc7006d-a482-47c4-a138-5380ce9278122025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.4ad879d4-eb32-49f0-af73-c47fc75819362025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.450ad3aa-7c9e-497b-b00e-b1af0322f8d02025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.0151c742-7525-4707-af03-bd48d50cd5862025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.281f9c32-e28a-46ae-9e4e-c2143aaa6c6b2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.aa90bf0b-c08d-43e5-b247-1a5c5e3c94e42025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.73cd20d5-2521-4b93-a221-fa3fe490eba62025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepackdde7b33e-84fc-41c9-97f8-10308841200d2025-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals, Inc.4af2a165-0b7d-2539-e054-00144ff8d46c2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.1c49ef5c-75bb-f9d4-e063-6394a90a951a2025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.946dbeaa-17ec-4049-e053-2995a90a14622025-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.fd784ff4-86ec-9ea4-e053-6394a90a89692025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.65e59e7a-0ec6-2a76-e053-2991aa0a00212024-12-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435
Penicillin V PotassiumPENICILLIN V POTASSIUMA-S Medication Solutions887a719a-4e5f-4e04-9935-7ad7ce75cabe2024-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065435
application number: ANDA065435

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSN8c11af69-146f-47ed-b12a-7b201fec7e505
834102penicillin V potassium 500 MG Oral TabletSCD8c11af69-146f-47ed-b12a-7b201fec7e505
834102Penicillin V K+ 500 MG Oral TabletSY8c11af69-146f-47ed-b12a-7b201fec7e505
834102Penicillin V Pot 500 MG Oral TabletSY8c11af69-146f-47ed-b12a-7b201fec7e505

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42708-098-144270800981414 TABLET, FILM COATED in 1 BOTTLE (42708-098-14) 2019-03-200000-00-00YesNoCurrent