Penicillin V Potassium

Product NDC
68071-2778
11-digit product format
680712778
Labeler code
68071
Product ID
68071-2778_e2aeebcb-c8a4-660e-e053-2995a90ab603
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090549
Marketing category
ANDA
Marketing start
2013-10-11
Marketing end
0000-00-00
Substance
PENICILLIN V POTASSIUM
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2778IInactivated by FDA2026-08-07
excluded packagepackage68071-277868071-2778-6IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2778-6IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2778-6IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2778-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2778-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2778-6IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2778-6IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2778-6UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2778-6UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2778-6UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A090549-001PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11
A090549-002PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090549-001AB
A090549-002AB

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 UTC2026-02A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11782e0a99824c…

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 UTC2026-02A090549-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090549-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090549-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090549-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090549-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090549-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090549-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090549-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090549-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090549-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090549-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090549-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090549-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090549-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090549-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090549-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090549-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090549-002AB1782e0a99824c…

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
68071-2778-62025-01-30C16284748780-12cef2736-6fac-d83d-e063-dadaa90ab31fPenicillin V Potassium Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2778-6Penicillin V Potassium6 in 1 BOTTLETABLET, FILM COATED61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2778PENICILLIN V POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220702_e2adf44c-5e0d-e974-e053-2995a90a3d16.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.5f0759cc-c553-49b9-9049-80e7137589582026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepack609c3e26-9220-4f3c-b393-a2b41b68de6c2026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.ceddc406-4a17-471f-917e-63b4b03779ea2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.a251a769-280e-4024-ad7a-3177463258182025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepackbdffe8fe-e6e0-4c08-894c-0653605ff4332025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPreferred Pharmaceuticals Inc.56192625-0564-4131-94b2-8b9c6a0b53b02025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.8d98ea77-f237-4b93-87fa-41f556436ab52025-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.7aef4c8b-aee7-453d-bb6f-fce8e4588e3b2025-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.fbd3f219-d052-fd00-e053-6294a90a66ac2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.f3f5947d-0dd3-4b50-93a2-bc83251809782025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMA-S Medication Solutions93c1177c-35da-464b-be90-bb18fe9bd27d2024-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMHikma Pharmaceuticals USA Inc.dc33f7a4-348b-4b4c-a5f2-c4f908fda4aa2024-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMA-S Medication Solutionse4642fb3-2db9-49d3-8fd4-ceb750f704372023-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834102penicillin V potassium 500 MG Oral TabletPSNe2adf44c-5e0d-e974-e053-2995a90a3d161
834102penicillin V potassium 500 MG Oral TabletSCDe2adf44c-5e0d-e974-e053-2995a90a3d161
834102Penicillin V K+ 500 MG Oral TabletSYe2adf44c-5e0d-e974-e053-2995a90a3d161
834102Penicillin V Pot 500 MG Oral TabletSYe2adf44c-5e0d-e974-e053-2995a90a3d161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2778-6680712778066 TABLET, FILM COATED in 1 BOTTLE (68071-2778-6) 2022-06-300000-00-00NoNoCurrent