Penicillin V Potassium

Product NDC
50090-3374
11-digit product format
500903374
Labeler code
50090
Product ID
50090-3374_cc9f3ae7-f5ae-4432-9455-e3f9ff5e5c67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Penicillin V Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090549
Marketing category
ANDA
Marketing start
2013-10-11
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
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…

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
93c1177c-35da-464b-be90-bb18fe9bd27dAvailable 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
50090-3374-0Penicillin V Potassium20 in 1 BOTTLETABLET, FILM COATED209
50090-3374-2Penicillin V Potassium28 in 1 BOTTLETABLET, FILM COATED289
50090-3374-3Penicillin V Potassium30 in 1 BOTTLETABLET, FILM COATED309
50090-3374-4Penicillin V Potassium40 in 1 BOTTLETABLET, FILM COATED409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3374-0EA - Each50090-33745dd2540c-09e6-405b-a902-b40a61436e3912021-09-07
50090-3374-2EA - Each50090-3374dd026179-0f4b-45f8-b694-50b9f990553612019-05-02
50090-3374-3EA - Each50090-337470af31d2-3836-406c-b246-35024ba0cc0312019-05-02
50090-3374-4EA - Each50090-3374f273f34d-4255-4b74-ba76-58590f900d2612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3374PENICILLIN V POTASSIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 4 package rows20241025_93c1177c-35da-464b-be90-bb18fe9bd27d.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
ndc (product): 50090-3374
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
834061penicillin V potassium 250 MG Oral TabletPSN93c1177c-35da-464b-be90-bb18fe9bd27d9
834061penicillin V potassium 250 MG Oral TabletSCD93c1177c-35da-464b-be90-bb18fe9bd27d9
834061Penicillin V K+ 250 MG Oral TabletSY93c1177c-35da-464b-be90-bb18fe9bd27d9
834061Penicillin V Pot 250 MG Oral TabletSY93c1177c-35da-464b-be90-bb18fe9bd27d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3374-05009033740020 TABLET, FILM COATED in 1 BOTTLE (50090-3374-0) 2018-10-080000-00-00NoNoCurrent
50090-3374-25009033740228 TABLET, FILM COATED in 1 BOTTLE (50090-3374-2) 2018-04-050000-00-00NoNoCurrent
50090-3374-35009033740330 TABLET, FILM COATED in 1 BOTTLE (50090-3374-3) 2018-04-060000-00-00NoNoCurrent
50090-3374-45009033740440 TABLET, FILM COATED in 1 BOTTLE (50090-3374-4) 2018-02-160000-00-00NoNoCurrent