Penicillin G Potassium

Product NDC
70860-126
Requested package NDC
70860-126-20
11-digit product format
708600126
Labeler code
70860
Product ID
70860-126_3fdb186f-4196-41dc-b88a-d6dbe194c070
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin g potassium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA065448
Marketing category
ANDA
Marketing start
2019-05-21
Marketing end
0000-00-00
Substance
PENICILLIN G POTASSIUM
Active strength
5000000 [iU]/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70860-12670860-126-20DDiscontinued by firm2026-08-03

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70860-12670860-126-20DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A065448-001PENICILLIN G POTASSIUMPENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18
A065448-002PENICILLIN G POTASSIUMPENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065448-001AP
A065448-002AP

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 UTC2026-02A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065448-001PENICILLIN G POTASSIUM5,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A065448-002PENICILLIN G POTASSIUM20,000,000 UNITS/VIALINJECTABLE / INJECTIONAP2009-08-18782e0a99824c…

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 UTC2026-02A065448-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065448-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065448-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065448-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065448-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065448-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065448-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065448-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065448-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065448-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065448-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065448-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065448-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065448-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065448-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065448-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065448-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065448-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065448-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065448-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065448-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065448-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065448-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065448-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065448-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065448-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065448-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065448-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065448-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065448-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065448-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065448-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065448-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065448-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065448-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065448-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065448-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065448-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065448-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065448-002AP1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea092e41-01a8-4781-b199-b94446808a52Product name120190205
af7816cd-473e-4681-8ef5-5d4b569ced61Product name120151014
b37c02b5-6cf5-47fd-aab5-d510a02bbac0Product name120151014
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0f47357f-4a94-e9f0-4fab-2eb6732c6263Product name120140508
11e45d82-8b7a-98b7-67b2-842a15f88536Product name120140508
6ccfe771-a97a-e261-3fb2-bf8e525d1fe0Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-126-202024-03-05C16284748780-11030e365-492b-111a-e063-dadaa90a10e2Penicillin G Potassium for Injection, USP
70860-126-202024-01-30C16284748780-11030e365-492b-111a-e063-dadaa90a10e2Penicillin G Potassium for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70860-126-20Penicillin G Potassium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION103
70860-126-41Penicillin G Potassium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-126-20EA - Each70860-1263a35d4dd-6ef5-4e8d-82cf-755fa115e14c12020-01-03
70860-126-41EA - Each70860-126ce044f15-86e0-4f74-b0bf-c1cbeb99fac112020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-126PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]3Legacy NDC, 2 package rows20250130_1442486a-05d6-4dce-8b95-857a30f478c2.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMHF Acquisition Co LLC, DBA HealthFirst56ab659e-ad28-028f-e063-6394a90a69432026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
Penicillin G PotassiumPENICILLIN G POTASSIUMWG Critical Care, LLCe0ced9d8-b9ea-466e-bf2c-10e9cc636f3f2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
PENICILLIN G POTASSIUMPENICILLIN G POTASSIUMHF Acquisition Co LLC, DBA HealthFirst50c7500f-be06-01af-e063-6294a90a01352026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
Penicillin G PotassiumPENICILLIN G POTASSIUMAvenacy Inc.969a421e-37d8-499e-9e89-67e210bd5d9d2025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
Penicillin G PotassiumPENICILLIN G POTASSIUMAthenex Pharmaceutical Division, LLC.1442486a-05d6-4dce-8b95-857a30f478c22025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
ndc (package): 70860-126-20
ndc (product): 70860-126
ndc11 (package): 70860012620
Penicillin G PotassiumPENICILLIN G POTASSIUMSagent Pharmaceuticalsfb2f3afe-0072-4383-bad8-9da9e94db4f22024-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448
Penicillin G PotassiumPENICILLIN G POTASSIUMNorthStar Rx, LLC8732b7ff-2e47-4f99-aadf-81861b431f4f2024-06-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065448
application number: ANDA065448

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionPSN1442486a-05d6-4dce-8b95-857a30f478c23
863538penicillin G potassium 1000000 UNT/ML Injectable SolutionSCD1442486a-05d6-4dce-8b95-857a30f478c23
863538Penicillin G K+ 1000000 UNT/ML Injectable SolutionSY1442486a-05d6-4dce-8b95-857a30f478c23
863538Penicillin G Pot 1000000 UNT/ML Injectable SolutionSY1442486a-05d6-4dce-8b95-857a30f478c23
863538penicillin G potassium 1,000,000 UNT/ML Injectable SolutionSY1442486a-05d6-4dce-8b95-857a30f478c23
863538penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable SolutionSY1442486a-05d6-4dce-8b95-857a30f478c23
863538penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable SolutionSY1442486a-05d6-4dce-8b95-857a30f478c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-126-207086001262010 VIAL in 1 CARTON (70860-126-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70860-126-41) 10 vial2019-05-210000-00-00NoNoCurrent