Penicillin V Potassium

Product NDC
68071-2244
11-digit product format
680712244
Labeler code
68071
Product ID
68071-2244_1d7676bc-ea2e-5cb2-e063-6394a90ac2ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA060711
Marketing category
ANDA
Marketing start
1990-09-30
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
A060711-002PENICILLIN-VKPENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALABApproved before 1982
A060711-003PENICILLIN-VKPENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALABApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A060711-002AB
A060711-003AB

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 UTC2026-02A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A060711-002PENICILLIN-VKEQ 250MG BASETABLET / ORALABApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A060711-003PENICILLIN-VKEQ 500MG BASETABLET / ORALABApproved before 1982782e0a99824c…

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 UTC2026-02A060711-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A060711-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A060711-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A060711-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A060711-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A060711-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A060711-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A060711-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A060711-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A060711-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A060711-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A060711-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A060711-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A060711-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A060711-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A060711-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A060711-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A060711-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A060711-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A060711-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A060711-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A060711-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A060711-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A060711-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A060711-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A060711-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A060711-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A060711-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A060711-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A060711-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A060711-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A060711-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A060711-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A060711-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A060711-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A060711-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A060711-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A060711-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A060711-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A060711-003AB1782e0a99824c…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penicillin V PotassiumPENICILLIN V POTASSIUMChartwell RX, LLCb0744674-ddf7-4022-be2f-2a22bef0d3792026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060711
application number: ANDA060711
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.dd8a48b2-9ff1-49de-a53e-db4964c2384c2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060711
application number: ANDA060711
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.ada3be87-2cdb-75f7-e053-2995a90aa95b2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060711
application number: ANDA060711
ndc (product): 68071-2244
Penicillin V PotassiumPENICILLIN V POTASSIUMTeva Pharmaceuticals USA, Inc.3111ca84-6f8e-45ea-91a1-9cb99c63607e2023-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 060711
application number: ANDA060711

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
ada3be87-2cdb-75f7-e053-2995a90aa95bAvailable on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2244-6Penicillin V Potassium6 in 1 BOTTLETABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2244PENICILLIN V POTASSIUM TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240719_ada3be87-2cdb-75f7-e053-2995a90aa95b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834061penicillin V potassium 250 MG Oral TabletPSNada3be87-2cdb-75f7-e053-2995a90aa95b3
834061penicillin V potassium 250 MG Oral TabletSCDada3be87-2cdb-75f7-e053-2995a90aa95b3
834061Penicillin V K+ 250 MG Oral TabletSYada3be87-2cdb-75f7-e053-2995a90aa95b3
834061Penicillin V Pot 250 MG Oral TabletSYada3be87-2cdb-75f7-e053-2995a90aa95b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2244-6680712244066 TABLET in 1 BOTTLE (68071-2244-6) 6 tablet2020-08-240000-00-00NoNoCurrent