Home NDC 50742-283 Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Product NDC 50742-283
11-digit product format 507420283
Labeler code 50742
Product ID 50742-283_6842c7a1-52e9-4047-81e1-22da3ec35505
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA217511
Marketing category ANDA
Marketing start 2023-07-04
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 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217511-001 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 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217511-001 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE 140MG;125MG;125MG CAPSULE / ORAL AB 2023-07-03 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A217511-001 CGT 2023-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217511-001 CGT 2023-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217511-001 CGT 2023-12-29 9b2671bbb829…
Additional Listing Data#
Finished product Yes
Brand name base Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Listing expiration 2026-12-31 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 50742-283-13 Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride 120 in 1 CARTON CAPSULE 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-283 BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDE CAPSULE [INGENUS PHARMACEUTICALS, LLC] 2 Current NDC, 1 package rows 20241024_4c7f024d-ba26-43cf-a36f-597e2168cd9f.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 50742-283-13 50742028313 120 CAPSULE in 1 CARTON (50742-283-13) 120 capsule 2023-07-04 No No Current