FDA.reportPublic FDA data

PYLERA

Product NDC
61269-380
11-digit product format
612690380
Labeler code
61269
Product ID
61269-380_07e2c55d-707f-4e3f-be0e-385da673b8ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, and TETRACYCLINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
H2-Pharma, LLC
Application
NDA050786
Marketing category
NDA
Marketing start
2023-10-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PYLERA
Listing expiration
2026-12-31

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, 1294621

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
61269-380-12PYLERA12 in 1 BLISTER PACKCAPSULE123
61269-380-12PYLERA10 in 1 BOXCAPSULE103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-380-12EA - Each61269-380b52d1482-b8ae-494a-8f82-b9a42eea017b12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-380PYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE) CAPSULE [H2-PHARMA, LLC]3Current NDC, 2 package rows20250411_5cdacbf5-67be-42eb-bd54-8acc32ea1abc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1294619bismuth subcitrate 140 MG / metroNIDAZOLE 125 MG / tetracycline HCl 125 MG Oral CapsulePSN5cdacbf5-67be-42eb-bd54-8acc32ea1abc3
1294621PYLERA 140 MG / 125 MG / 125 MG Oral CapsulePSN5cdacbf5-67be-42eb-bd54-8acc32ea1abc3
1294621bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule [Pylera]SBD5cdacbf5-67be-42eb-bd54-8acc32ea1abc3
1294619bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral CapsuleSCD5cdacbf5-67be-42eb-bd54-8acc32ea1abc3
1294621Pylera (bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG) Oral CapsuleSY5cdacbf5-67be-42eb-bd54-8acc32ea1abc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61269-380-126126903801210 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK10 blister pack2023-10-01NoNoCurrent