Home NDC 0904-7461 POTASSIUM CHLORIDE
Product NDC 0904-7461
11-digit product format 009047461
Labeler code 0904
Product ID 0904-7461_0e0defca-901d-4b4b-ac96-ac72fcfe4303
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name POTASSIUM CHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA210766
Marketing category ANDA
Marketing start 2024-07-08
Substance POTASSIUM CHLORIDE
Active strength 20 meq/15mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210766-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 A210766-002 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210766-001 POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION / ORAL AA 2019-03-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210766-002 POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION / ORAL AA 2019-03-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base POTASSIUM CHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM CHLORIDE 20 meq/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 660YQ98I10 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312515 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 0904-7461-46 POTASSIUM CHLORIDE 30 in 1 CASE SOLUTION 30 8 0904-7461-47 POTASSIUM CHLORIDE 80 in 1 CASE SOLUTION 80 8 0904-7461-51 POTASSIUM CHLORIDE 50 in 1 CASE SOLUTION 50 8 0904-7461-80 POTASSIUM CHLORIDE 100 in 1 CASE SOLUTION 100 8 0904-7461-87 POTASSIUM CHLORIDE 40 in 1 CASE SOLUTION 40 8 0904-7461-88 POTASSIUM CHLORIDE 15 mL in 1 CUP, UNIT-DOSE SOLUTION 15 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7461 POTASSIUM CHLORIDE SOLUTION [MAJOR PHARMACEUTICALS] 7 Current NDC, 6 package rows 20241116_33ad1eb2-1f05-461c-b01d-82dee4231556.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 0904-7461-46 00904746146 30 CUP, UNIT-DOSE in 1 CASE (0904-7461-46) / 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88) 2024-07-08 2027-02-28 No No Historical 0904-7461-47 00904746147 80 CUP, UNIT-DOSE in 1 CASE (0904-7461-47) / 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88) 2024-07-11 2026-10-31 No No Historical 0904-7461-51 00904746151 50 CUP, UNIT-DOSE in 1 CASE (0904-7461-51) / 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88) 2024-07-08 No No Current 0904-7461-80 00904746180 100 CUP, UNIT-DOSE in 1 CASE (0904-7461-80) / 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88) 2024-07-08 2027-02-28 No No Historical 0904-7461-87 00904746187 40 CUP, UNIT-DOSE in 1 CASE (0904-7461-87) / 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88) 2024-07-08 No No Current 0904-7461-88 00904746188 15 mL in 1 CUP, UNIT-DOSE (0904-7461-88) 15 ml 2024-07-08 No No Current