Home NDC 61269-380 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
Marketing end 2027-07-31
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050786-001 PYLERA BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050786-001 AB
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.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table 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 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL AB RLD, RS 2006-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050786-001 PYLERA 140MG;125MG;125MG CAPSULE / ORAL RLD, RS 2006-09-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base PYLERA Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBCITRATE POTASSIUM 140 mg/1 METRONIDAZOLE 125 mg/1 TETRACYCLINE HYDROCHLORIDE 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R3O80H60KX Internal UNII lookup 140QMO216E Internal UNII lookup P6R62377KV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1294619 Internal RxNorm lookup 1294621 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61269-380-12 PYLERA 12 in 1 BLISTER PACK CAPSULE 12 3 61269-380-12 PYLERA 10 in 1 BOX CAPSULE 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61269-380 PYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE) CAPSULE [H2-PHARMA, LLC] 3 Current NDC, 2 package rows 20250411_5cdacbf5-67be-42eb-bd54-8acc32ea1abc.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.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PYLERA BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE H2-Pharma, LLC 5cdacbf5-67be-42eb-bd54-8acc32ea1abc 2026-06-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 050786 application number: NDA050786 ndc (product): 61269-380 Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE H2-Pharma, LLC c29bfde9-5eb4-422a-bd30-4bce45e73dc0 2026-04-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 050786 application number: NDA050786 PYLERA BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE H2-Pharma, LLC c50626a2-5969-490b-a88a-a4ee45e79615 2026-01-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 050786 application number: NDA050786
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61269-380-12 61269038012 10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK 10 blister pack 2023-10-01 2027-07-31 No No Historical