FDA.reportPublic FDA data

NDC 61133-5803-3 - TetraMed 324 HCA

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
61133-5803
Requested NDC
61133-5803-3
Package NDCs from labels
61133-5803-4, 61133-5803-5, 61133-5803-1, 61133-5803-2, 61133-5803-3
Manufacturer
Bimeda, Inc.
Effective date
2024-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TetraMed 324 HCA - Bimeda, Inc.Bimeda, Inc.2024-10-07PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61133-5803-1TetraMed 324 HCA.1417 kg in 1 POUCHPOWDER.141712
61133-5803-2TetraMed 324 HCA.9072 kg in 1 POUCHPOWDER.907212
61133-5803-3TetraMed 324 HCA1.134 kg in 1 POUCHPOWDER1.13412
61133-5803-4TetraMed 324 HCA2.27 kg in 1 PAILPOWDER2.2712
61133-5803-5TetraMed 324 HCA11.34 kg in 1 PAILPOWDER11.3412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61133-5803TETRAMED 324 HCA (TETRACYCLINE HYDROCHLORIDE) POWDER [BIMEDA, INC.]125 package rows20241009_bc723e31-99f6-40cb-94ab-1b64d359fa0d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tetracycline hydrochlorideACTIVE INGREDIENTP6R62377KVTETRAMED 324 HCA (TETRACYCLINE HYDROCHLORIDE) POWDER [BIMEDA, INC. DIVISION OF CROSS VETPHARM GROUP]3
tetracyclineACTIVE MOIETYF8VB5M810TTETRAMED 324 HCA (TETRACYCLINE HYDROCHLORIDE) POWDER [BIMEDA, INC. DIVISION OF CROSS VETPHARM GROUP]3

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBryant Ranch Prepack02e88b4a-57ae-4ef6-ba48-97c657202b942026-08-11Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
PYLERABISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLC5cdacbf5-67be-42eb-bd54-8acc32ea1abc2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc. .ccd30048-a226-455f-971b-5dbf14b22e9d2026-06-11Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Vitastem-tetracycline hydrochlorideTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.7ffe82a4-864b-48c7-9307-d262f20ca01e2026-05-26WarningsExact identifier
unii: P6R62377KV
Viaderma Vitastem First Aid Topical AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC6eb04a76-7995-4df6-9c9b-dd450537e5382026-05-26WarningsExact identifier
unii: P6R62377KV
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.00acf413-c5d2-4a54-9d0d-56266cbc9edc2026-05-22Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBryant Ranch Prepack22208459-3e6f-46a7-9f7f-f2c254a381322026-05-12Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEProficient Rx LPd48071a0-c397-42f8-b8ad-158282e745e32026-05-01Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCb504e612-5aef-47fa-8f7b-dfb754011b9f2026-04-14Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline HydrochlorideBISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLCc29bfde9-5eb4-422a-bd30-4bce45e73dc02026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline HydrochlorideBISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDEPar Health USA, LLCc4d66e80-f0bc-4e64-a0f0-630ef673da1b2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
PYLERABISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLCc50626a2-5969-490b-a88a-a4ee45e796152026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
ViaDerma Care Tetracycline HCl First Aid AntibioticTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.5437777e-7f2b-412d-a2f5-380c09de4b1d2026-01-14WarningsExact identifier
unii: P6R62377KV
Vitastem First Aid AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC3970ac49-ab0f-4492-ba61-95a12faed5002025-12-02WarningsExact identifier
unii: P6R62377KV
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochlorideBISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC4c7f024d-ba26-43cf-a36f-597e2168cd9f2025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3ce3e8dc-7fbd-4f8d-a65f-092e1ef217252025-11-06Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCae29aa18-6efb-47c9-bbd7-cbe8af1b7f382025-04-24Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEActavis Pharma, Inc.32a409a0-fea6-411a-8218-c1c7df46d6642025-04-09Warnings, Adverse reactionsExact identifier
unii: P6R62377KV
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC13c1f2df-ba52-45e0-8868-a7518e9cdb552025-04-07WarningsExact identifier
unii: P6R62377KV
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC93a6e02e-9f4b-4821-afa2-2029769f30882025-04-07WarningsExact identifier
unii: P6R62377KV

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.