Home NDC 0143-9339 Sterile Water
Product NDC 0143-9339
11-digit product format 001439339
Labeler code 0143
Product ID 0143-9339_2558c762-cdc9-4135-a83e-8d4c5c9d1afc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sterile Water
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA212735
Marketing category ANDA
Marketing start 2023-05-05
Substance WATER
Active strength 1 mL/mL
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 42 .
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 A212735-001 STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212735-001 AP
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 2026-08-18 06:07:40 2026-07 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212735-001 STERILE WATER FOR INJECTION 100% LIQUID / N/A AP 2023-01-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sterile Water
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WATER 1 mL/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 059QF0KO0R Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9339-12 Sterile Water 12 in 1 CASE INJECTION, SOLUTION 12 4 0143-9339-12 Sterile Water 1000 mL in 1 BAG INJECTION, SOLUTION 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9339 STERILE WATER INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, 2 package rows 20230509_b20a28b0-7dfa-42eb-9177-ec256d5a5ef7.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0143-9339-12 00143933912 12 BAG in 1 CASE (0143-9339-12) / 1000 mL in 1 BAG 12 bag 2023-05-05 No No Current