Home NDC 44567-310 Penicillin G Potassium
Product NDC 44567-310
11-digit product format 445670310
Labeler code 44567
Product ID 44567-310_b7d807b1-f742-4e96-bb34-3e832b985303
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Penicillin G Potassium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler WG Critical Care, LLC
Application ANDA065149
Marketing category ANDA
Marketing start 2012-05-10
Substance PENICILLIN G POTASSIUM
Active strength 1000000 [iU]/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065149-001 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 A065149-002 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 A065149-003 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065149-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065149-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2009-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065149-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL INJECTABLE / INJECTION 2009-07-23 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Penicillin G Potassium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENICILLIN G POTASSIUM 1000000 [iU]/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44567-310-10 Penicillin G Potassium 10 in 1 TRAY INJECTION, POWDER, FOR SOLUTION 10 11 44567-310-10 Penicillin G Potassium 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-310 PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] 10 Current NDC, Legacy NDC, 2 package rows 20250502_e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 863538 penicillin G potassium 1,000,000 UNT/ML Injectable Solution PSN e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f 11 863538 penicillin G potassium 1000000 UNT/ML Injectable Solution SCD e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f 11 863538 Penicillin G K+ 1000000 UNT/ML Injectable Solution SY e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f 11 863538 Penicillin G Pot 1000000 UNT/ML Injectable Solution SY e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f 11 863538 penicillin G potassium 1,000,000 UNT/ML Injectable Solution SY e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f 11 863538 penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable Solution SY e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f 11 863538 penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable Solution SY e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f 11
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44567-310-10 44567031010 10 VIAL in 1 TRAY (44567-310-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 10 vial 2012-05-10 0000-00-00 No No Current