BICILLIN CR
- Product NDC
- 60793-601
- 11-digit product format
- 607930601
- Labeler code
- 60793
- Product ID
- 60793-601_b5d01048-1d94-4a82-9a67-fdddd23235a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- penicillin G benzathine and penicillin G procaine
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA050138
- Marketing category
- NDA
- Marketing start
- 1953-05-18
- Substance
- PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
- Active strength
- 600000; 600000 [iU]/2mL; [iU]/2mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050138-001 | BICILLIN C-R | PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | ||
| N050138-002 | BICILLIN C-R | PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N050138-003 | BICILLIN C-R 900/300 | PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, 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.
| 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 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050138-002 | BICILLIN C-R | 150,000 UNITS/ML;150,000 UNITS/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050138-003 | BICILLIN C-R 900/300 | 900,000 UNITS/2ML;300,000 UNITS/2ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050138-001 | BICILLIN C-R | 300,000 UNITS/ML;300,000 UNITS/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BICILLIN CR
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PENICILLIN G BENZATHINE | 600000 [iU]/2mL |
| PENICILLIN G PROCAINE | 600000 [iU]/2mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RIT82F58GK | Internal UNII lookup |
| 17R794ESYN | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b5640fc6-76d8-428d-80e6-760d769af8bb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ea092e41-01a8-4781-b199-b94446808a52 | Product name | 1 | 20190205 |
| af7816cd-473e-4681-8ef5-5d4b569ced61 | Product name | 1 | 20151014 |
| b37c02b5-6cf5-47fd-aab5-d510a02bbac0 | Product name | 1 | 20151014 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0f47357f-4a94-e9f0-4fab-2eb6732c6263 | Product name | 1 | 20140508 |
| 11e45d82-8b7a-98b7-67b2-842a15f88536 | Product name | 1 | 20140508 |
| 6ccfe771-a97a-e261-3fb2-bf8e525d1fe0 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60793-601-02 | BICILLIN CR | 2 mL in 1 SYRINGE | INJECTION, SUSPENSION | 2 | 27 | |
| 60793-601-10 | BICILLIN CR | 10 in 1 PACKAGE | INJECTION, SUSPENSION | 10 | 27 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60793-601-02 | ML - Milliliter | 60793-601 | e32e9bea-25c8-426f-87a4-8a5dc906f642 | 1 | 2015-03-03 |
| 60793-601-10 | ML - Milliliter | 60793-601 | 6cf67928-cdb5-4bc9-8ff0-d37c9fdaaee4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60793-601 | BICILLIN CR (PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE) INJECTION, SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] | 27 | Current NDC, Legacy NDC, 2 package rows | 20240606_b5640fc6-76d8-428d-80e6-760d769af8bb.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BICILLIN C-R 900/300 | PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE | Pfizer Laboratories Div Pfizer Inc | ba7b9199-4710-4189-a85d-77ed75befe4d | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 050138 NDA050138 |
| BICILLIN CR | PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE | Pfizer Laboratories Div Pfizer Inc | b5640fc6-76d8-428d-80e6-760d769af8bb | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 050138 NDA050138 60793-601 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 731541 | BICILLIN C-R 1,200,000 UNT in 2 ML Prefilled Syringe | PSN | b5640fc6-76d8-428d-80e6-760d769af8bb | 27 |
| 731538 | penicillin G benzathine / penicillin G procaine 1,200,000 UNT (600,000 UNT/ 600,000 UNT) in 2 ML Prefilled Syringe | PSN | b5640fc6-76d8-428d-80e6-760d769af8bb | 27 |
| 731541 | 2 ML penicillin G benzathine 300000 UNT/ML / penicillin G procaine 300000 UNT/ML Prefilled Syringe [Bicillin] | SBD | b5640fc6-76d8-428d-80e6-760d769af8bb | 27 |
| 731538 | 2 ML penicillin G benzathine 300000 UNT/ML / penicillin G procaine 300000 UNT/ML Prefilled Syringe | SCD | b5640fc6-76d8-428d-80e6-760d769af8bb | 27 |
| 731541 | Bicillin C-R (penicillin G benzathine 600,000 UNT / penicillin G procaine 600,000 UNT) per 2 ML Prefilled Syringe | SY | b5640fc6-76d8-428d-80e6-760d769af8bb | 27 |
| 731541 | Bicillin C-R 1.2 Million per 2 ML (600,000 UNT / 600,000 UNT) Prefilled Syringe | SY | b5640fc6-76d8-428d-80e6-760d769af8bb | 27 |
| 731538 | penicillin G benzathine 600,000 UNT / penicillin G procaine 600000 UNT per 2 ML Prefilled Syringe | SY | b5640fc6-76d8-428d-80e6-760d769af8bb | 27 |
| 731541 | BICILLIN C-R 1,200,000 UNT in 2 ML Prefilled Syringe | PSN | 4bd2cd7a-327d-48ed-9e8b-e6a03e3188d9 | 2 |
| 731538 | penicillin G benzathine / penicillin G procaine 1,200,000 UNT (600,000 UNT/ 600,000 UNT) in 2 ML Prefilled Syringe | PSN | 4bd2cd7a-327d-48ed-9e8b-e6a03e3188d9 | 2 |
| 731541 | 2 ML penicillin G benzathine 300000 UNT/ML / penicillin G procaine 300000 UNT/ML Prefilled Syringe [Bicillin] | SBD | 4bd2cd7a-327d-48ed-9e8b-e6a03e3188d9 | 2 |
| 731538 | 2 ML penicillin G benzathine 300000 UNT/ML / penicillin G procaine 300000 UNT/ML Prefilled Syringe | SCD | 4bd2cd7a-327d-48ed-9e8b-e6a03e3188d9 | 2 |
| 731541 | Bicillin C-R (penicillin G benzathine 600,000 UNT / penicillin G procaine 600,000 UNT) per 2 ML Prefilled Syringe | SY | 4bd2cd7a-327d-48ed-9e8b-e6a03e3188d9 | 2 |
| 731541 | Bicillin C-R 1.2 Million per 2 ML (600,000 UNT / 600,000 UNT) Prefilled Syringe | SY | 4bd2cd7a-327d-48ed-9e8b-e6a03e3188d9 | 2 |
| 731538 | penicillin G benzathine 600,000 UNT / penicillin G procaine 600000 UNT per 2 ML Prefilled Syringe | SY | 4bd2cd7a-327d-48ed-9e8b-e6a03e3188d9 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60793-601-02 | 60793060102 | 2 mL in 1 SYRINGE | 2 ml | Historical | ||||
| 60793-601-10 | 60793060110 | 10 SYRINGE in 1 PACKAGE (60793-601-10) / 2 mL in 1 SYRINGE (60793-601-02) | 10 syringe | 1953-05-18 | 0000-00-00 | No | No | Current |