FDA.reportPublic FDA data

Cromolyn Sodium

Product NDC
42571-350
11-digit product format
425710350
Labeler code
42571
Product ID
42571-350_22feddbf-0d9b-8ce7-e063-6394a90a8887
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
INHALANT
Route
INTRABRONCHIAL
Labeler
Micro Labs Limited
Application
ANDA213658
Marketing category
ANDA
Marketing start
2022-06-01
Substance
CROMOLYN SODIUM
Active strength
20 mg/2mL
Pharmacologic classes
Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42571-350DDiscontinued by firm2026-08-17
excluded packagepackage42571-35042571-350-09DDiscontinued by firm2026-08-17
excluded packagepackage42571-35042571-350-50DDiscontinued by firm2026-08-17

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213658-001CROMOLYN SODIUMCROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A213658-001AN

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-295c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213658-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONAN2022-04-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213658-001AN1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213658-001AN1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213658-001AN131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213658-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213658-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213658-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213658-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213658-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213658-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213658-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213658-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213658-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213658-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213658-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213658-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213658-001AN15c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213658-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213658-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213658-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213658-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213658-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213658-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213658-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213658-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213658-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213658-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213658-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213658-001AN1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213658-001AN1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213658-001AN1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d745b171-bd61-e8c6-cc94-d4add278788bProduct name320230113
a7fea5a7-679e-334b-faff-75e43fb3beb5Product name220171208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-350-08Cromolyn Sodium2 mL in 1 AMPULEINHALANT22
42571-350-09Cromolyn Sodium5 in 1 CARTONINHALANT52
42571-350-09Cromolyn Sodium12 in 1 CARTONINHALANT122
42571-350-50Cromolyn Sodium12 in 1 CARTONINHALANT122
42571-350-50Cromolyn Sodium10 in 1 CARTONINHALANT102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-350-08ML - Milliliter42571-350d3e0d1d9-c63b-4f84-8ab0-02eec611684112025-05-14
42571-350-09ML - Milliliter42571-350f0a9963c-33f0-4a3f-8f20-7f8686ba97f212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-350CROMOLYN SODIUM (CROMOLYN SODIUM) INHALANT [MICRO LABS LIMITED]2Current NDC, Legacy NDC, 5 package rows20240927_aebec664-ed80-447c-9789-0cf47c8b7429.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831246cromolyn sodium 20 MG in 2 ML Inhalation SolutionPSNaebec664-ed80-447c-9789-0cf47c8b74292
831246cromolyn sodium 10 MG/ML Inhalation SolutionSCDaebec664-ed80-447c-9789-0cf47c8b74292
831246cromolyn sodium 20 MG per 2 ML Inhalation SolutionSYaebec664-ed80-447c-9789-0cf47c8b74292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-350-08425710350082 mL in 1 AMPULE2 mlHistorical
42571-350-09425710350095 CARTON in 1 CARTON (42571-350-09) / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08) 5 carton2022-06-010000-00-00NoNoCurrent
42571-350-504257103505010 CARTON in 1 CARTON (42571-350-50) / 12 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (42571-350-08) 10 carton2022-06-010000-00-00NoNoCurrent