Home NDC 81665-104 CROMOLYN SODIUM
Product NDC 81665-104
11-digit product format 816650104
Labeler code 81665
Product ID 81665-104_fd09b0f1-907c-4d4d-a693-9756efd60f20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CROMOLYN SODIUM
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Omnivium Pharmaceuticals LLC
Application ANDA209264
Marketing category ANDA
Marketing start 2024-08-31
Substance CROMOLYN SODIUM
Active strength 100 mg/5mL
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 A209264-001 CROMOLYN SODIUM CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209264-001 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.
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 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209264-001 CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA 2017-10-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 100 mg/5mL
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 831261 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 81665-104-96 CROMOLYN SODIUM 8 in 1 POUCH SOLUTION, CONCENTRATE 8 2 81665-104-96 CROMOLYN SODIUM 12 in 1 CARTON SOLUTION, CONCENTRATE 12 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81665-104 CROMOLYN SODIUM SOLUTION, CONCENTRATE [OMNIVIUM PHARMACEUTICALS LLC] 1 Current NDC, 2 package rows 20240911_a742664b-265e-49f9-9744-d04e1fb620ae.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 81665-104-96 81665010496 12 POUCH in 1 CARTON (81665-104-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE 12 pouch 2024-08-31 No No Current