Home NDC 0641-0497 Sodium Chloride
Product NDC 0641-0497
11-digit product format 006410497
Labeler code 0641
Product ID 0641-0497_0950e98d-bfec-40e8-9f56-ba90e0d6e8c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Chloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA201833
Marketing category ANDA
Marketing start 2013-09-24
Substance SODIUM CHLORIDE
Active strength 9 mg/mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [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 42 .
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 A201833-001 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 A201833-002 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201833-002 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.
Product history page 1 of 2 · 64 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 2026-08-18 06:07:40 2026-07 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201833-001 SODIUM CHLORIDE 0.9% 9MG/ML INJECTABLE / INJECTION 2013-09-24 c0c555d07b60…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sodium Chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CHLORIDE 9 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 451W47IQ8X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807636 Internal RxNorm lookup 1807637 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 0641-0497-17 Sodium Chloride 2 mL in 1 VIAL INJECTION 2 12 0641-0497-25 Sodium Chloride 25 in 1 CARTON INJECTION 25 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-0497 SODIUM CHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 12 Current NDC, Legacy NDC, 2 package rows 20240412_e5ee8caa-b6ca-45ba-98fb-8305e6282141.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 Marketing end Sample Exclude flag Status 0641-0497-17 00641049717 2 mL in 1 VIAL 2 ml Historical 0641-0497-25 00641049725 25 VIAL in 1 CARTON (0641-0497-25) / 2 mL in 1 VIAL (0641-0497-17) 25 vial 2013-09-24 0000-00-00 No No Current