Home NDC 70954-197-20 Potassium chloride
Product NDC 70954-197
Requested package NDC 70954-197-20
11-digit product format 709540197
Labeler code 70954
Product ID 70954-197_0128a879-7185-4b70-b0bb-d108ff1c9542
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium chloride
Dosage form FOR SOLUTION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA212816
Marketing category ANDA
Marketing start 2023-07-19
Substance POTASSIUM CHLORIDE
Active strength 1.5 g/1.56g
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 43 .
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 A212816-001 POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212816-001 AA
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 2026-09-14 22:38:34 2026-08 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212816-001 POTASSIUM CHLORIDE 20MEQ FOR SOLUTION / ORAL AA 2023-07-12 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Potassium chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM CHLORIDE 1.5 g/1.56g
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 1867544 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 70954-197-10 Potassium chloride 1.56 g in 1 POUCH FOR SOLUTION 1.56 1 70954-197-20 Potassium chloride 30 in 1 CARTON FOR SOLUTION 30 1 70954-197-30 Potassium chloride 100 in 1 CARTON FOR SOLUTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-197 POTASSIUM CHLORIDE FOR SOLUTION [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 3 package rows 20230722_0128a879-7185-4b70-b0bb-d108ff1c9542.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 70954-197-20 70954019720 30 POUCH in 1 CARTON (70954-197-20) / 1.56 g in 1 POUCH (70954-197-10) 30 pouch 2023-07-19 No No Current