FDA.reportPublic FDA data

Cromolyn Sodium

Product NDC
0172-6406
11-digit product format
001726406
Labeler code
0172
Product ID
0172-6406_38833b9a-b1dd-4e33-b8a3-806fa99eb4a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
SOLUTION
Route
INTRABRONCHIAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075271
Marketing category
ANDA
Marketing start
2000-01-18
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075271-001CROMOLYN SODIUMCROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONANRS2000-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075271-001AN

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
2026-08-01 22:54:322026-06A075271-001CROMOLYN SODIUM10MG/MLSOLUTION / INHALATIONANRS2000-01-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075271-001AN1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cromolyn SodiumCROMOLYN SODIUMTeva Pharmaceuticals USA, Inc.8fe37a7a-edd6-4733-bb7e-e01c1906aeba2023-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075271
application number: ANDA075271
ndc (product): 0172-6406

Additional Listing Data#

Finished product
Yes
Brand name base
Cromolyn Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CROMOLYN SODIUM20 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q2WXR1I0PKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
831246Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8fe37a7a-edd6-4733-bb7e-e01c1906aebaAvailable on FDA.report

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
0172-6406-05Cromolyn Sodium2 mL in 1 VIAL, SINGLE-DOSESOLUTION29
0172-6406-05Cromolyn Sodium5 in 1 POUCHSOLUTION59
0172-6406-49Cromolyn Sodium12 in 1 CARTONSOLUTION129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0172-6406-05ML - Milliliter0172-64066bc54976-9530-45b5-bc30-cf12377e21b012015-05-05
0172-6406-49ML - Milliliter0172-64068ea1bd01-526a-4f58-a460-0ed81f61952d12012-07-24
0172-6406-59ML - Milliliter0172-6406ca7a2596-94b6-4733-872e-5f49965417b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CROMOLYN SODIUMACTIVE INGREDIENTQ2WXR1I0PKCROMOLYN SODIUM SOLUTION [IVAX PHARMACEUTICALS, INC.]3
CROMOLYNACTIVE MOIETYY0TK0FS77WCROMOLYN SODIUM SOLUTION [IVAX PHARMACEUTICALS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RCROMOLYN SODIUM SOLUTION [IVAX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0172-6406CROMOLYN SODIUM SOLUTION [TEVA PHARMACEUTICALS USA, INC.]9Current NDC, Legacy NDC, 3 package rows20240201_8fe37a7a-edd6-4733-bb7e-e01c1906aeba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831246cromolyn sodium 20 MG in 2 ML Inhalation SolutionPSN8fe37a7a-edd6-4733-bb7e-e01c1906aeba9
831246cromolyn sodium 10 MG/ML Inhalation SolutionSCD8fe37a7a-edd6-4733-bb7e-e01c1906aeba9
831246cromolyn sodium 20 MG per 2 ML Inhalation SolutionSY8fe37a7a-edd6-4733-bb7e-e01c1906aeba9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0172-6406-05001726406052 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
0172-6406-490017264064912 POUCH in 1 CARTON (0172-6406-49) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0172-6406-05) / 2 mL in 1 VIAL, SINGLE-DOSE12 pouch2000-01-180000-00-00NoNoCurrent