Cromolyn Sodium Inhalation Solution

Product NDC: 76204-028
11-digit product format: 762040028
Labeler code: 76204
Product ID: 76204-028_459fa0f5-35dd-d6e5-e063-6394a90a6f14
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cromolyn Sodium Inhalation Solution
Dosage form: SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Ritedose Pharmaceuticals, LLC
Application: ANDA209453
Marketing category: ANDA
Marketing start: 2021-12-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76204-028		I	Inactivated by FDA		2026-08-03
excluded package	package	76204-028	76204-028-60	I	Inactivated by FDA		2026-08-03

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
A209453-001	CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN		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
A209453-001	AN

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209453-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2017-10-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209453-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209453-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209453-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209453-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209453-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209453-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209453-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209453-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209453-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209453-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209453-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209453-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209453-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209453-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209453-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209453-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209453-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209453-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209453-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209453-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209453-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209453-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209453-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209453-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209453-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209453-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209453-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209453-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209453-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209453-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209453-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209453-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209453-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209453-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209453-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209453-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209453-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209453-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209453-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209453-001	AN	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d745b171-bd61-e8c6-cc94-d4add278788b	Product name	3	20230113
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
76204-028-12	Cromolyn Sodium Inhalation Solution	2 mL in 1 AMPULE	SOLUTION	2	6
76204-028-12	Cromolyn Sodium Inhalation Solution	30 in 1 POUCH	SOLUTION	30	6
76204-028-60	Cromolyn Sodium Inhalation Solution	2 in 1 CARTON	SOLUTION	2	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76204-028-12	ML - Milliliter	76204-028	ae1bd5b0-873f-49af-9ca6-843f061c97f7	1	2024-04-05
76204-028-60	ML - Milliliter	76204-028	920839ef-a122-4631-88e2-e93ab80e5d3a	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76204-028	CROMOLYN SODIUM INHALATION SOLUTION SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]	4	Current NDC, 3 package rows	20241219_0209cd6c-5c43-0b93-e063-6294a90ac964.zip

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
831246	cromolyn sodium 20 MG in 2 ML Inhalation Solution	PSN	0209cd6c-5c43-0b93-e063-6294a90ac964	6
831246	cromolyn sodium 10 MG/ML Inhalation Solution	SCD	0209cd6c-5c43-0b93-e063-6294a90ac964	6
831246	cromolyn sodium 20 MG per 2 ML Inhalation Solution	SY	0209cd6c-5c43-0b93-e063-6294a90ac964	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76204-028-12	76204002812	2 mL in 1 AMPULE	2 ml				Historical
76204-028-60	76204002860	2 POUCH in 1 CARTON (76204-028-60) / 30 AMPULE in 1 POUCH (76204-028-12) / 2 mL in 1 AMPULE	2 pouch	2021-12-01	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cromolyn Sodium Inhalation Solution, 20 mg/2 mL	Ritedose Pharmaceuticals, LLC	2025-12-10	HUMAN PRESCRIPTION DRUG LABEL	6