BICILLIN CR

Product NDC
50090-1815
11-digit product format
500901815
Labeler code
50090
Product ID
50090-1815_7ec1d1c1-b84b-4087-b33b-3963017fd95b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
penicillin G benzathine and penicillin G procaine
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
NDA050138
Marketing category
NDA
Marketing start
1953-05-18
Marketing end
0000-00-00
Substance
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
Active strength
600000 [iU]/2mL; [iU]/2mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-1815IInactivated by FDA2026-08-11
excluded packagepackage50090-181550090-1815-0IInactivated by FDA2026-08-11

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-1815-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-1815-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-1815-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-1815-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-1815-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-1815-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-1815-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-1815-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-1815-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-1815-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-1815-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-1815-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-1815-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-1815-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-1815-01332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-1815-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-1815-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-1815-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-1815-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-1815-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-1815-09bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050138-001BICILLIN C-RPENICILLIN G BENZATHINE; PENICILLIN G PROCAINE300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982
N050138-002BICILLIN C-RPENICILLIN G BENZATHINE; PENICILLIN G PROCAINE150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982
N050138-003BICILLIN C-R 900/300PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050138-002BICILLIN C-R150,000 UNITS/ML;150,000 UNITS/MLINJECTABLE / INJECTIONRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050138-003BICILLIN C-R 900/300900,000 UNITS/2ML;300,000 UNITS/2MLINJECTABLE / INJECTIONRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050138-001BICILLIN C-R300,000 UNITS/ML;300,000 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19828072bd15b7f6…

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
0f47357f-4a94-e9f0-4fab-2eb6732c6263Product name120140508
11e45d82-8b7a-98b7-67b2-842a15f88536Product name120140508
6ccfe771-a97a-e261-3fb2-bf8e525d1fe0Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1815-0BICILLIN CR2 mL in 1 SYRINGEINJECTION, SUSPENSION23
50090-1815-0BICILLIN CR10 in 1 PACKAGEINJECTION, SUSPENSION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1815BICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20180115_34d52db0-b34d-4860-bed6-d57a87e4bf27.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BICILLIN C-R 900/300PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINEPfizer Laboratories Div Pfizer Incba7b9199-4710-4189-a85d-77ed75befe4d2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050138
application number: NDA050138
BICILLIN CRPENICILLIN G BENZATHINE AND PENICILLIN G PROCAINEPfizer Laboratories Div Pfizer Incb5640fc6-76d8-428d-80e6-760d769af8bb2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050138
application number: NDA050138

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731541BICILLIN C-R 1,200,000 UNT in 2 ML Prefilled SyringePSN34d52db0-b34d-4860-bed6-d57a87e4bf273
731538penicillin G benzathine / penicillin G procaine 1,200,000 UNT (600,000 UNT/ 600,000 UNT) in 2 ML Prefilled SyringePSN34d52db0-b34d-4860-bed6-d57a87e4bf273
7315412 ML penicillin G benzathine 300000 UNT/ML / penicillin G procaine 300000 UNT/ML Prefilled Syringe [Bicillin]SBD34d52db0-b34d-4860-bed6-d57a87e4bf273
7315382 ML penicillin G benzathine 300000 UNT/ML / penicillin G procaine 300000 UNT/ML Prefilled SyringeSCD34d52db0-b34d-4860-bed6-d57a87e4bf273
731541Bicillin C-R (penicillin G benzathine 600,000 UNT / penicillin G procaine 600,000 UNT) per 2 ML Prefilled SyringeSY34d52db0-b34d-4860-bed6-d57a87e4bf273
731541Bicillin C-R 1.2 Million per 2 ML (600,000 UNT / 600,000 UNT) Prefilled SyringeSY34d52db0-b34d-4860-bed6-d57a87e4bf273
731538penicillin G benzathine 600,000 UNT / penicillin G procaine 600000 UNT per 2 ML Prefilled SyringeSY34d52db0-b34d-4860-bed6-d57a87e4bf273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50090-1815-0500901815002 mL in 1 SYRINGE2 mlHistorical