FDA.reportPublic FDA data

Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride

Product NDC
49884-151
11-digit product format
498840151
Labeler code
49884
Product ID
49884-151_1ba717f8-b210-40c9-a16e-85edbddaba02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA205770
Marketing category
ANDA
Marketing start
2023-03-07
Substance
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Active strength
140; 125; 125 mg/1; mg/1; mg/1
Pharmacologic classes
Bismuth [CS], Bismuth [EPC], Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS], Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBCITRATE POTASSIUM140 mg/1
METRONIDAZOLE125 mg/1
TETRACYCLINE HYDROCHLORIDE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR3O80H60KX, 140QMO216E, P6R62377KV
Rxcui1294619

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55Product name520251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17Product name120250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1Product name520250515
e1aac33b-94ae-4ee9-905b-299f7263853bProduct name320250124
16642716-d28a-4f90-8dcb-3921cd8c8109Product name420240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
151122cd-8b80-4972-8b02-3a4dda642fbcProduct name220200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-151-54Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride120 in 1 CARTONCAPSULE12018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-151-24EA - Each49884-151f0c3cacf-1bfc-44bc-b582-c5b11572b0b912023-04-07
49884-151-54EA - Each49884-1512bc40a42-8729-4950-895b-a29d7e3f600f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-151BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE CAPSULE [ENDO USA, INC.]16Current NDC, 1 package rows20250112_c4d66e80-f0bc-4e64-a0f0-630ef673da1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1294619bismuth subcitrate 140 MG / metroNIDAZOLE 125 MG / tetracycline HCl 125 MG Oral CapsulePSNc4d66e80-f0bc-4e64-a0f0-630ef673da1b18
1294619bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral CapsuleSCDc4d66e80-f0bc-4e64-a0f0-630ef673da1b18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49884-151-5449884015154120 CAPSULE in 1 CARTON (49884-151-54) 120 capsule2023-03-07NoNoCurrent