Home NDC 49884-151 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 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 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205770-001 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.
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 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205770-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-03-06 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1294619 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 49884-151-54 Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride 120 in 1 CARTON CAPSULE 120 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-151 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE CAPSULE [ENDO USA, INC.] 16 Current NDC, 1 package rows 20250112_c4d66e80-f0bc-4e64-a0f0-630ef673da1b.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49884-151-54 49884015154 120 CAPSULE in 1 CARTON (49884-151-54) 120 capsule 2023-03-07 No No Current