Home NDC 68788-8490 Cromolyn Sodium
Product NDC 68788-8490
11-digit product format 687888490
Labeler code 68788
Product ID 68788-8490_378bf83b-f080-45f8-a53a-0dc2f32f4cac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cromolyn Sodium
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Preferred Pharmaceuticals Inc.
Application ANDA075282
Marketing category ANDA
Marketing start 2023-07-21
Substance CROMOLYN SODIUM
Active strength 40 mg/mL
Pharmacologic classes Decreased Histamine Release [PE], Mast Cell Stabilizer [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 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 A075282-001 CROMOLYN SODIUM CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16
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 · 42 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 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC RS 1999-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075282-001 CROMOLYN SODIUM 4% SOLUTION/DROPS / OPHTHALMIC AT 1999-06-16 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cromolyn Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CROMOLYN SODIUM 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q2WXR1I0PK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 831109 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 68788-8490-1 Cromolyn Sodium 10 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8490 CROMOLYN SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.] 3 Current NDC, 1 package rows 20250312_18892411-465f-4d8d-9550-7dafa6c6a0a3.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 · 4 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 68788-8490-1 68788849001 10 mL in 1 BOTTLE, PLASTIC (68788-8490-1) 10 ml 2023-07-21 No No Current