NDC 49281-561 - PENTACEL
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 49281-561
- Package NDCs from labels
- 49281-561-01
- Manufacturer
- Sanofi Vaccines US Inc. | Sanofi Vaccines Canada Ltd.
- Effective date
- 2026-04-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| PENTACEL - Sanofi Vaccines US Inc. | Sanofi Vaccines Canada Ltd. | Sanofi Vaccines US Inc. | Sanofi Vaccines Canada Ltd. | 2026-04-28 | VACCINE LABEL |
| PENTACEL - A-S Medication Solutions | A-S Medication Solutions | 2025-05-16 | VACCINE LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49281-561-01 | PENTACEL | 0.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 2.5 mL | 26 [D'ag'U] in 0.5mL | 13 |
| 49281-561-01 | PENTACEL | 0.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 2.5 mL | 7 [D'ag'U] in 0.5mL | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49281-561 | PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [SANOFI PASTEUR INC.] | 9 | Unmatched | 20250403_67d5c665-ca88-49ba-b7d3-7145d9878cf0.zip |
| 49281-561 | PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE) KIT [A-S MEDICATION SOLUTIONS] | 1 | Unmatched | 20250523_e7a819d7-a597-4c91-9078-7cd20ac34410.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 |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Addiclenz | BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Deseret Biologicals, Inc. | e39235ea-2a2f-44a7-92d6-fb1d428ebabd | 2022-05-12 | Warnings | 1HG84L3525 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE | Proficient Rx LP | 98042cef-2839-49d6-a7bd-a1d29c74430b | 2022-05-02 | Warnings, Adverse reactions | 19371312D4 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE | Proficient Rx LP | 601cab21-c211-4c34-be7b-f4fdd97a921a | 2022-05-02 | Warnings, Adverse reactions | 19371312D4 |
| Polymyxin B | POLYMYXIN B SULFATE | Hikma Pharmaceuticals USA Inc. | 18daf0d1-b6f5-46f4-ab2f-01a594f3959c | 2022-04-28 | Boxed warning, Warnings, Adverse reactions | 19371312D4 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | Proficient Rx LP | 1252b997-3a81-4f3c-90e4-92f29ba15713 | 2022-04-01 | Warnings, Adverse reactions | 19371312D4 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE | Proficient Rx LP | d1f55327-156f-44cd-b0fc-b1a938e8aa73 | 2022-04-01 | Warnings, Adverse reactions | 19371312D4 |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Cuadriderma | BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE | ProMex LLC | 4fa99b96-ab4b-4523-82bc-343dbaf39fb6 | 2022-01-25 | Warnings | 19371312D4 |
| TH-101 | CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROB | Temple Health Nutrition, LLC | d54bb860-560c-4f8f-9aea-a0b7774cc92b | 2021-12-29 | Warnings | C151H8M554 |
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE | Sandoz Inc | 96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d | 2021-08-31 | Warnings, Adverse reactions | 19371312D4 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE | Sandoz Inc. | 99d9030f-9118-412c-a377-d1df1c8fa723 | 2021-08-31 | Warnings, Adverse reactions | 19371312D4 |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
| POLYMYXIN B | POLYMYXIN B SULFATE | Fresenius Kabi USA, LLC | 704a41f5-b109-4c16-8d3e-1495c9917952 | 2021-05-31 | Boxed warning, Warnings, Adverse reactions | 19371312D4 |
| POLYMYXIN B | POLYMYXIN B SULFATE | Fresenius Kabi USA, LLC | fbc12c18-567b-41bc-89d0-efd29616615c | 2021-02-28 | Boxed warning, Warnings, Adverse reactions | 19371312D4 |
| Sterile Water | WATER | Asclemed USA, Inc. | 45c38269-883c-4198-a9d5-03810a4420ec | 2021-01-14 | Warnings, Adverse reactions | 059QF0KO0R |
| Neomycin and Polymyxin B Sulfates and Dexamethasone | NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE | Proficient Rx LP | bd9f3220-6d42-4863-aa2a-b17b138d095d | 2021-01-01 | Warnings, Adverse reactions | 19371312D4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.