Penicillin V Potassium

Product NDC
68071-3562
Requested package NDC
68071-3562-4
11-digit product format
680713562
Labeler code
68071
Product ID
68071-3562_0fb8ab8a-5aa8-e6f4-e063-6294a90a1af6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065435
Marketing category
ANDA
Marketing start
2008-04-29
Substance
PENICILLIN V POTASSIUM
Active strength
250 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 POTASSIUM250 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
834061Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0fb8ab8a-5aa7-e6f4-e063-6294a90a1af6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9c9e02f7-1420-b137-8de0-89820016e6caProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3562-4Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3562PENICILLIN V POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20240125_0fb8ab8a-5aa7-e6f4-e063-6294a90a1af6.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
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
834061penicillin V potassium 250 MG Oral TabletPSN0fb8ab8a-5aa7-e6f4-e063-6294a90a1af61
834061penicillin V potassium 250 MG Oral TabletSCD0fb8ab8a-5aa7-e6f4-e063-6294a90a1af61
834061Penicillin V K+ 250 MG Oral TabletSY0fb8ab8a-5aa7-e6f4-e063-6294a90a1af61
834061Penicillin V Pot 250 MG Oral TabletSY0fb8ab8a-5aa7-e6f4-e063-6294a90a1af61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3562-46807135620440 TABLET, FILM COATED in 1 BOTTLE (68071-3562-4) 2024-01-24NoNoCurrent