Cromolyn Sodium Oral Solution (Concentrate)

Product NDC: 76204-025
11-digit product format: 762040025
Labeler code: 76204
Product ID: 76204-025_eff7da0a-4836-6ebd-e053-2995a90ab3c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cromolyn Sodium Oral Solution (Concentrate)
Dosage form: SOLUTION, CONCENTRATE
Route: ORAL
Labeler: Ritedose Pharmaceuticals, LLC
Application: ANDA209264
Marketing category: ANDA
Marketing start: 2021-12-01
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76204-025		I	Inactivated by FDA		2026-10-05
excluded package	package	76204-025	76204-025-96	I	Inactivated by FDA		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209264-001	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE / ORAL	AA	2017-10-16	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209264-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209264-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209264-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209264-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209264-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209264-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209264-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209264-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209264-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209264-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209264-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209264-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209264-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209264-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209264-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209264-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209264-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209264-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209264-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209264-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209264-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209264-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209264-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209264-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209264-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209264-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209264-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209264-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209264-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209264-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209264-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209264-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209264-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209264-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209264-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209264-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209264-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209264-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209264-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209264-001	AA	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d745b171-bd61-e8c6-cc94-d4add278788b	Product name	3	20230113
a7fea5a7-679e-334b-faff-75e43fb3beb5	Product name	2	20171208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76204-025-08	Cromolyn Sodium Oral Solution (Concentrate)	5 mL in 1 AMPULE	SOLUTION, CONCENTRATE	5	10
76204-025-08	Cromolyn Sodium Oral Solution (Concentrate)	8 in 1 POUCH	SOLUTION, CONCENTRATE	8	10
76204-025-96	Cromolyn Sodium Oral Solution (Concentrate)	12 in 1 CARTON	SOLUTION, CONCENTRATE	12	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76204-025-96	ML - Milliliter	76204-025	b1e954d0-daa0-41b6-a2e6-cbd67386d359	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76204-025	CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE) SOLUTION, CONCENTRATE [RITEDOSE PHARMACEUTICALS, LLC]	8	Legacy NDC, 3 package rows	20241219_d208df15-c823-6e0d-e053-2a95a90ad1be.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CROMOLYN SODIUM	CROMOLYN SODIUM	Omnivium Pharmaceuticals LLC	a742664b-265e-49f9-9744-d04e1fb620ae	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209264 application number: ANDA209264

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q2WXR1I0PK	CROMOLYN SODIUM	15826-37-6	CROMOLYN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
831261	cromolyn sodium 100 MG in 5 mL Concentrate for Oral Solution	PSN	d208df15-c823-6e0d-e053-2a95a90ad1be	10
831261	cromolyn sodium 20 MG/ML Oral Solution	SCD	d208df15-c823-6e0d-e053-2a95a90ad1be	10
831261	cromolyn sodium 100 MG per 5 ML Concentrate for Oral Solution	SY	d208df15-c823-6e0d-e053-2a95a90ad1be	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76204-025-08	76204002508	5 mL in 1 AMPULE	5 ml					Historical
76204-025-96	76204002596	1 POUCH in 1 CARTON (76204-025-96) > 96 AMPULE in 1 POUCH (76204-025-08) > 5 mL in 1 AMPULE	1 pouch	2021-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL	Ritedose Pharmaceuticals, LLC	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	10