Pylera

Product NDC
58914-601
11-digit product format
589140601
Labeler code
58914
Product ID
58914-601_8ba040ec-d48a-45e8-a2e2-3e3b9ca7c41d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA050786
Marketing category
NDA
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Active strength
140 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58914-601DDiscontinued by firm2026-08-10
excluded packagepackage58914-60158914-601-20DDiscontinued by firm2026-08-10
excluded packagepackage58914-60158914-601-21DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58914-601-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58914-601-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58914-601-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58914-601-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58914-601-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58914-601-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58914-601-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58914-601-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58914-601-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58914-601-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58914-601-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58914-601-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58914-601-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58914-601-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58914-601-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58914-601-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58914-601-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58914-601-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58914-601-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58914-601-21ad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050786-001PYLERABISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N050786-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALABRLD, RS2006-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050786-001PYLERA140MG;125MG;125MGCAPSULE / ORALRLD, RS2006-09-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050786-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050786-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050786-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050786-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050786-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050786-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050786-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050786-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050786-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050786-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050786-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050786-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050786-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050786-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050786-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050786-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050786-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050786-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050786-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050786-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050786-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050786-001AB1053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050786-001AB1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58914-601-20EA - Each58914-6015ca2fda0-d4dd-4e67-bb17-633e498d41f712013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bismuth subcitrate potassiumACTIVE INGREDIENTR3O80H60KXPYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10
MetronidazoleACTIVE INGREDIENT140QMO216EPYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10
Tetracycline hydrochlorideACTIVE INGREDIENTP6R62377KVPYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YEPYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10
MetronidazoleACTIVE MOIETY140QMO216EPYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10
TetracyclineACTIVE MOIETYF8VB5M810TPYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10
GelatinINACTIVE INGREDIENT2G86QN327LPYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10
Magnesium stearateINACTIVE INGREDIENT70097M6I30PYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10
TalcINACTIVE INGREDIENT7SEV7J4R1UPYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPYLERA (BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE) CAPSULE [APTALIS PHARMA US, INC.]10

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PYLERABISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLC5cdacbf5-67be-42eb-bd54-8acc32ea1abc2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050786
application number: NDA050786
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
application applno (NDA): 050786
application number: NDA050786
PYLERABISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLCc50626a2-5969-490b-a88a-a4ee45e796152026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 050786
application number: NDA050786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58914-601-20589140601201 BLISTER PACK in 1 BOX (58914-601-20) > 120 CAPSULE in 1 BLISTER PACK1 blister pack2013-08-010000-00-00NoNoCurrent
58914-601-21589140601211 BOTTLE in 1 BOX (58914-601-21) > 120 CAPSULE in 1 BOTTLE1 bottle2013-08-010000-00-00NoNoCurrent