Home NDC 0781-6136 Penicillin G Potassium
Product NDC 0781-6136
11-digit product format 007816136
Labeler code 0781
Product ID 0781-6136_e76e56d8-13b5-4520-8aa3-9202ceef1a03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Penicillin G Potassium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sandoz Inc
Application ANDA065079
Marketing category ANDA
Marketing start 2001-08-30
Substance PENICILLIN G POTASSIUM
Active strength 20000000 [iU]/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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065079-001 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 A065079-002 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 A065079-003 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065079-002 PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065079-003 PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP 2002-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065079-001 PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION 2002-08-30 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Penicillin G Potassium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENICILLIN G POTASSIUM 20000000 [iU]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VL775ZTH4C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 863538 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-6136-94 Penicillin G Potassium 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 17 0781-6136-94 Penicillin G Potassium 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PENICILLIN G POTASSIUM ACTIVE INGREDIENT VL775ZTH4C PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 14 PENICILLIN G ACTIVE MOIETY Q42T66VG0C PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 14 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 14 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-6136 PENICILLIN G POTASSIUM INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 17 Current NDC, Legacy NDC, 2 package rows 20201107_91950983-4884-40d1-abd8-bcc953d61b7f.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 · 2 matching rows.
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 91950983-4884-40d1-abd8-bcc953d61b7f 17 863538 penicillin G potassium 1000000 UNT/ML Injectable Solution SCD 91950983-4884-40d1-abd8-bcc953d61b7f 17 863538 Penicillin G K+ 1000000 UNT/ML Injectable Solution SY 91950983-4884-40d1-abd8-bcc953d61b7f 17 863538 Penicillin G Pot 1000000 UNT/ML Injectable Solution SY 91950983-4884-40d1-abd8-bcc953d61b7f 17 863538 penicillin G potassium 1,000,000 UNT/ML Injectable Solution SY 91950983-4884-40d1-abd8-bcc953d61b7f 17 863538 penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable Solution SY 91950983-4884-40d1-abd8-bcc953d61b7f 17 863538 penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable Solution SY 91950983-4884-40d1-abd8-bcc953d61b7f 17
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-6136-94 00781613694 1 VIAL in 1 CARTON (0781-6136-94) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 1 vial 2001-08-30 0000-00-00 No No Current