cromolyn sodium

Product NDC: 51525-0470
Requested package NDC: 51525-0470-9
11-digit product format: 515250470
Labeler code: 51525
Product ID: 51525-0470_b70d4285-ddb4-4e80-baf1-340f9572d903
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cromolyn sodium
Dosage form: SOLUTION
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA020479
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-10-21
Marketing end: 2026-06-30
Substance: CROMOLYN SODIUM
Active strength: 100 mg/5mL
Pharmacologic classes: Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
NDC exclude flag: No
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51525-0470	51525-0470-9	D	Discontinued by firm		2026-08-11

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
N020479-001	GASTROCROM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020479-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020479-001	GASTROCROM	100MG/5ML	CONCENTRATE / ORAL	AA	RLD, RS	1996-02-29	`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	N020479-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020479-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020479-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020479-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020479-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020479-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020479-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020479-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020479-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020479-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020479-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020479-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020479-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020479-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020479-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020479-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020479-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020479-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020479-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020479-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020479-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020479-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020479-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020479-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020479-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020479-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020479-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020479-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020479-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020479-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020479-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020479-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020479-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020479-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020479-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020479-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020479-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020479-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020479-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020479-001	AA	1	`cb3db0bc1861…`

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
51525-0470-8	cromolyn sodium	8 in 1 POUCH	SOLUTION	8	9
51525-0470-8	cromolyn sodium	5 mL in 1 AMPULE	SOLUTION	5	9
51525-0470-9	cromolyn sodium	12 in 1 CARTON	SOLUTION	12	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51525-0470-8	ML - Milliliter	51525-0470	ad116182-b75f-46a6-9c21-32a681a91f12	1	2015-10-02
51525-0470-9	ML - Milliliter	51525-0470	f1ec620d-40de-4be1-b5c3-63fcff501005	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CROMOLYN SODIUM	ACTIVE INGREDIENT	Q2WXR1I0PK	CROMOLYN SODIUM (CROMOLYN) SOLUTION [WALLACE PHARMACEUTICALS INC.]	2
CROMOLYN	ACTIVE MOIETY	Y0TK0FS77W	CROMOLYN SODIUM (CROMOLYN) SOLUTION [WALLACE PHARMACEUTICALS INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CROMOLYN SODIUM (CROMOLYN) SOLUTION [WALLACE PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51525-0470	CROMOLYN SODIUM SOLUTION [WALLACE PHARMACEUTICALS INC.]	8	Current NDC, Legacy NDC, 3 package rows	20240210_fbefd5bd-668a-4d10-b93e-a2e3fc5dddbd.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
Gastrocrom	CROMOLYN SODIUM	Viatris Specialty LLC	00623958-a8fe-47d1-a0d2-0aa4e2f7966e	2024-06-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020479 application number: NDA020479

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	fbefd5bd-668a-4d10-b93e-a2e3fc5dddbd	9
831261	cromolyn sodium 20 MG/ML Oral Solution	SCD	fbefd5bd-668a-4d10-b93e-a2e3fc5dddbd	9
831261	cromolyn sodium 100 MG per 5 ML Concentrate for Oral Solution	SY	fbefd5bd-668a-4d10-b93e-a2e3fc5dddbd	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51525-0470-9	51525047009	12 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 5 mL in 1 AMPULE	12 pouch	2015-10-21	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cromolyn Sodium, USP For Oral Use Only – Not for Inhalation or Injection.	Mylan Pharmaceuticals Inc.	2023-06-20	HUMAN PRESCRIPTION DRUG LABEL	9