Home NDC 0049-0430 Pfizerpen
Product NDC 0049-0430
11-digit product format 000490430
Labeler code 0049
Product ID 0049-0430_9bbe1112-d804-49de-bdff-245ce94872f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name penicillin G potassium
Dosage form POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Roerig
Application ANDA060657
Marketing category ANDA
Marketing start 2010-06-01
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 A060657-001 PFIZERPEN PENICILLIN G POTASSIUM 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 A060657-002 PFIZERPEN PENICILLIN G POTASSIUM 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 A060657-003 PFIZERPEN PENICILLIN G POTASSIUM 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982
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 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A060657-002 PFIZERPEN 5,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A060657-003 PFIZERPEN 20,000,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A060657-001 PFIZERPEN 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION Approved before 1982 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 Pfizerpen
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 863538 Internal RxNorm lookup 995906 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 0049-0430-20 Pfizerpen 1 in 1 CARTON POWDER, FOR SOLUTION 1 9 0049-0430-20 Pfizerpen 1 in 1 VIAL POWDER, FOR SOLUTION 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0049-0430 PFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG] 9 Current NDC, Legacy NDC, 2 package rows 20241215_2f7ea103-56cc-492f-b862-af45f9aed980.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 · 3 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 2f7ea103-56cc-492f-b862-af45f9aed980 9 995906 Pfizerpen 1,000,000 UNT/ML Injectable Solution PSN 2f7ea103-56cc-492f-b862-af45f9aed980 9 995906 penicillin G potassium 1000000 UNT/ML Injectable Solution [Pfizerpen] SBD 2f7ea103-56cc-492f-b862-af45f9aed980 9 863538 penicillin G potassium 1000000 UNT/ML Injectable Solution SCD 2f7ea103-56cc-492f-b862-af45f9aed980 9 863538 Penicillin G K+ 1000000 UNT/ML Injectable Solution SY 2f7ea103-56cc-492f-b862-af45f9aed980 9 995906 Penicillin G K+ 1000000 UNT/ML Injectable Solution [Pfizerpen] SY 2f7ea103-56cc-492f-b862-af45f9aed980 9 863538 Penicillin G Pot 1000000 UNT/ML Injectable Solution SY 2f7ea103-56cc-492f-b862-af45f9aed980 9 995906 Penicillin G Pot 1000000 UNT/ML Injectable Solution [Pfizerpen] SY 2f7ea103-56cc-492f-b862-af45f9aed980 9 863538 penicillin G potassium 1,000,000 UNT/ML Injectable Solution SY 2f7ea103-56cc-492f-b862-af45f9aed980 9 863538 penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable Solution SY 2f7ea103-56cc-492f-b862-af45f9aed980 9 863538 penicillin G potassium 5,000,000 UNT per 3.2 ML Injectable Solution SY 2f7ea103-56cc-492f-b862-af45f9aed980 9 995906 Pfizerpen 1,000,000 UNT/ML Injectable Solution SY 2f7ea103-56cc-492f-b862-af45f9aed980 9
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0049-0430-20 00049043020 1 VIAL in 1 CARTON (0049-0430-20) / 1 POWDER, FOR SOLUTION in 1 VIAL 1 vial 2018-03-30 0000-00-00 No No Current