Home NDC 0037-0678 Gastrocrom
Product NDC 0037-0678
11-digit product format 000370678
Labeler code 0037
Product ID 0037-0678_15aec235-80e7-4d95-b48c-bbca69b4b04d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cromolyn sodium
Dosage form LIQUID
Route ORAL
Labeler Viatris Specialty LLC
Application NDA020479
Marketing category NDA
Marketing start 2015-05-01
Substance CROMOLYN SODIUM
Active strength 20 mg/mL
Pharmacologic classes Decreased Histamine Release [PE], Mast Cell Stabilizer [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 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 N020479-001 GASTROCROM CROMOLYN SODIUM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020479-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020479-001 GASTROCROM 100MG/5ML CONCENTRATE / ORAL AA RLD, RS 1996-02-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Gastrocrom
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CROMOLYN SODIUM 20 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 831261 Internal RxNorm lookup 831269 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 0037-0678-08 Gastrocrom 5 mL in 1 AMPULE LIQUID 5 6 0037-0678-08 Gastrocrom 8 in 1 POUCH LIQUID 8 6 0037-0678-96 Gastrocrom 12 in 1 CARTON LIQUID 12 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0037-0678 GASTROCROM (CROMOLYN SODIUM) LIQUID [MEDA PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 3 package rows 20241101_00623958-a8fe-47d1-a0d2-0aa4e2f7966e.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 0037-0678-08 00037067808 5 mL in 1 AMPULE 5 ml Historical 0037-0678-96 00037067896 12 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE 12 pouch 2015-05-01 0000-00-00 No No Current