Home NDC 49884-117 Amiloride Hydrochloride
Product NDC 49884-117
11-digit product format 498840117
Labeler code 49884
Product ID 49884-117_cee18f3c-6f68-46d0-9e69-72c504c5a798
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amiloride Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Endo USA, Inc.
Application ANDA070346
Marketing category ANDA
Marketing start 1986-01-22
Substance AMILORIDE HYDROCHLORIDE ANHYDROUS
Active strength 5 mg/1
Pharmacologic classes Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC]
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 A070346-001 AMILORIDE HYDROCHLORIDE AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070346-001 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 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070346-001 AMILORIDE HYDROCHLORIDE 5MG TABLET / ORAL AB RS 1986-01-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Amiloride Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7M458Q65S3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 977880 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 49884-117-01 Amiloride Hydrochloride 100 in 1 BOTTLE TABLET 100 11 49884-117-10 Amiloride Hydrochloride 1000 in 1 BOTTLE TABLET 1000 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMILORIDE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT 7M458Q65S3 AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 5 AMILORIDE ACTIVE MOIETY 7DZO8EB0Z3 AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 5 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 5 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.] 5 AMILORIDE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT 7M458Q65S3 AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 AMILORIDE ACTIVE MOIETY 7DZO8EB0Z3 AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 AMILORIDE HYDROCHLORIDE ANHYDROUS ACTIVE INGREDIENT 7M458Q65S3 AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 AMILORIDE ACTIVE MOIETY 7DZO8EB0Z3 AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMILORIDE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-117 AMILORIDE HYDROCHLORIDE TABLET [ENDO USA, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20250109_e0cc2d44-436a-47e8-a890-589882fff4c4.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 · 2 matching rows.
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 49884-117-01 49884011701 100 TABLET in 1 BOTTLE (49884-117-01) 100 tablet 1986-05-12 0000-00-00 No No Current 49884-117-10 49884011710 1000 TABLET in 1 BOTTLE (49884-117-10) 1000 tablet 1986-05-12 0000-00-00 No No Current