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 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
A075271-001	CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075271-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075271-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	RS	2000-01-18	`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	A075271-001	AN	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075271-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075271-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075271-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075271-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075271-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075271-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075271-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075271-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075271-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075271-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075271-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075271-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075271-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075271-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075271-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075271-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075271-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075271-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075271-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075271-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075271-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075271-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075271-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075271-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075271-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075271-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075271-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075271-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075271-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075271-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075271-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075271-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075271-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075271-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075271-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075271-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075271-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075271-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075271-001	AN	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CROMOLYN SODIUM	20 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q2WXR1I0PK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
8fe37a7a-edd6-4733-bb7e-e01c1906aeba	Available on FDA.report

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
0172-6406-05	Cromolyn Sodium	2 mL in 1 VIAL, SINGLE-DOSE	SOLUTION	2	9
0172-6406-05	Cromolyn Sodium	5 in 1 POUCH	SOLUTION	5	9
0172-6406-49	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
0172-6406-05	ML - Milliliter	0172-6406	6bc54976-9530-45b5-bc30-cf12377e21b0	1	2015-05-05
0172-6406-49	ML - Milliliter	0172-6406	8ea1bd01-526a-4f58-a460-0ed81f61952d	1	2012-07-24
0172-6406-59	ML - Milliliter	0172-6406	ca7a2596-94b6-4733-872e-5f49965417b5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CROMOLYN SODIUM	ACTIVE INGREDIENT	Q2WXR1I0PK	CROMOLYN SODIUM SOLUTION [IVAX PHARMACEUTICALS, INC.]	3
CROMOLYN	ACTIVE MOIETY	Y0TK0FS77W	CROMOLYN SODIUM SOLUTION [IVAX PHARMACEUTICALS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CROMOLYN SODIUM SOLUTION [IVAX PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0172-6406	CROMOLYN SODIUM SOLUTION [TEVA PHARMACEUTICALS USA, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20240201_8fe37a7a-edd6-4733-bb7e-e01c1906aeba.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	Teva Pharmaceuticals USA, Inc.	8fe37a7a-edd6-4733-bb7e-e01c1906aeba	2023-12-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075271 application number: ANDA075271 ndc (product): 0172-6406

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	8fe37a7a-edd6-4733-bb7e-e01c1906aeba	9
831246	cromolyn sodium 10 MG/ML Inhalation Solution	SCD	8fe37a7a-edd6-4733-bb7e-e01c1906aeba	9
831246	cromolyn sodium 20 MG per 2 ML Inhalation Solution	SY	8fe37a7a-edd6-4733-bb7e-e01c1906aeba	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0172-6406-05	00172640605	2 mL in 1 VIAL, SINGLE-DOSE	2 ml					Historical
0172-6406-49	00172640649	12 POUCH in 1 CARTON (0172-6406-49) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0172-6406-05) / 2 mL in 1 VIAL, SINGLE-DOSE	12 pouch	2000-01-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cromolyn Sodium Inhalation Solution, USP Rx only	Teva Pharmaceuticals USA, Inc.	2023-12-14	HUMAN PRESCRIPTION DRUG LABEL	9