Home NDC 62135-833-84 Sterile Water
Product NDC 62135-833
Requested package NDC 62135-833-84
11-digit product format 621350833
Labeler code 62135
Product ID 62135-833_10594df5-e2d0-a24e-e063-6394a90afe26
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sterile Water
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Chartwell RX, LLC
Application ANDA211222
Marketing category ANDA
Marketing start 2021-06-07
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 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 A211222-001 STERILE WATER FOR INJECTION STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211222-001 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 2026-02-19 14:30 UTC 2026-02 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A 2021-02-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A 2021-02-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A RS 2021-02-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A RS 2021-02-10 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211222-001 STERILE WATER FOR INJECTION 100% (5ML) LIQUID / N/A AP 2021-02-10 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 62135-833-84 Sterile Water 30 in 1 CARTON INJECTION 30 2 62135-833-84 Sterile Water 5 mL in 1 VIAL, SINGLE-DOSE INJECTION 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-833 STERILE WATER INJECTION [CHARTWELL RX, LLC] 2 Current NDC, 2 package rows 20240202_3681eeaa-807a-47ca-9fbc-61c2b682800a.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62135-833-84 62135083384 30 VIAL, SINGLE-DOSE in 1 CARTON (62135-833-84) / 5 mL in 1 VIAL, SINGLE-DOSE 2024-01-25 No No Current