CROMOLYN SODIUM

Product NDC: 69784-200
11-digit product format: 697840200
Labeler code: 69784
Product ID: 69784-200_dde8609f-d587-4882-9a15-3fd5565dd2b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CROMOLYN SODIUM
Dosage form: SOLUTION, CONCENTRATE
Route: ORAL
Labeler: Woodward Pharma Services LLC
Application: ANDA209264
Marketing category: ANDA
Marketing start: 2017-10-16
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	69784-200		D	Discontinued by firm		2026-08-17
excluded package	package	69784-200	69784-200-96	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69784-200-96	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69784-200-96	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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-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 · 42 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
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	A209264-001	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE / ORAL	AA	2017-10-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A209264-001	AA	1	`e64feba35796…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69784-200-96	ML - Milliliter	69784-200	daf2e8ef-1d92-47fc-9703-5bcb066df14e	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69784-200	CROMOLYN SODIUM SOLUTION, CONCENTRATE [WOODWARD PHARMA SERVICES LLC]	7	Legacy NDC	20250114_6be24bee-c252-49d3-8352-399ad8394f2d.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	8b84de1e-0c12-40c9-8185-00878ec6ada6	107
831261	cromolyn sodium 20 MG/ML Oral Solution	SCD	8b84de1e-0c12-40c9-8185-00878ec6ada6	107
831261	cromolyn sodium 100 MG per 5 ML Concentrate for Oral Solution	SY	8b84de1e-0c12-40c9-8185-00878ec6ada6	107
831261	cromolyn sodium 100 MG in 5 mL Concentrate for Oral Solution	PSN	6440340a-990a-487f-9248-92b486dea5df	105
831261	cromolyn sodium 20 MG/ML Oral Solution	SCD	6440340a-990a-487f-9248-92b486dea5df	105
831261	cromolyn sodium 100 MG per 5 ML Concentrate for Oral Solution	SY	6440340a-990a-487f-9248-92b486dea5df	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69784-200-96	69784020096	12 POUCH in 1 CARTON (69784-200-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE	12 pouch	2017-10-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cromolyn Sodium Oral Solution, Concentrate	Bryant Ranch Prepack	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	102
Cromolyn Sodium Oral Solution, Concentrate	Bryant Ranch Prepack	2025-03-21	HUMAN PRESCRIPTION DRUG LABEL	105
Cromolyn Sodium Oral Solution, Concentrate	Woodward Pharma Services LLC	2025-01-12	HUMAN PRESCRIPTION DRUG LABEL	7
Cromolyn Sodium Oral Solution, Concentrate	Bryant Ranch Prepack	2024-09-12	HUMAN PRESCRIPTION DRUG LABEL	107