Acid Reducer Powder

Product NDC: 75907-237
11-digit product format: 759070237
Labeler code: 75907
Product ID: 75907-237_46176916-f5b6-7f16-2601-3885bca7659f
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole and Sodium Bicarbonate
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc.,
Application: ANDA217784
Marketing category: ANDA
Marketing start: 2024-07-15
Substance: OMEPRAZOLE; SODIUM BICARBONATE
Active strength: 20; 1680 mg/1; mg/1
Pharmacologic classes: Alkalinizing Activity [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
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 44.

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
A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL			2024-05-09

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217784-001	OMEPRAZOLE AND SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION / ORAL	2024-05-09	`a50c72e98297…`

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: Acid Reducer Powder
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	20 mg/1
SODIUM BICARBONATE	1680 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KG60484QX9	Internal UNII lookup
8MDF5V39QO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
753562	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
6f8452f8-8c2c-6700-a11d-1531023056c5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75907-237	ACID REDUCER POWDER (OMEPRAZOLE AND SODIUM BICARBONATE) POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC.,]	2	Current NDC	20250306_6f8452f8-8c2c-6700-a11d-1531023056c5.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acid Reducer Powder	OMEPRAZOLE AND SODIUM BICARBONATE	Dr. Reddy's Laboratories Inc.,	6f8452f8-8c2c-6700-a11d-1531023056c5	2025-03-03	Warnings	Exact identifier application applno (ANDA): 217784 application number: ANDA217784 ndc (product): 75907-237
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Dr. Reddy's Laboratories Inc.,	ddee28fb-c871-a6d4-984f-515522b28412	2024-07-15	Warnings	Exact identifier application applno (ANDA): 217784 application number: ANDA217784
Omeprazole and Sodium Bicarbonate	OMEPRAZOLE AND SODIUM BICARBONATE	Dr. Reddy's Laboratories Inc.,	c6b5f808-4a49-1303-9711-badb022ecd70	2023-07-19	Warnings	Exact identifier application applno (ANDA): 217784 application number: ANDA217784

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
753562	omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension	PSN	6f8452f8-8c2c-6700-a11d-1531023056c5	2
753562	omeprazole 20 MG / sodium bicarbonate 1680 MG Powder for Oral Suspension	SCD	6f8452f8-8c2c-6700-a11d-1531023056c5	2
753562	Omeprazole 20 MG / NaHCO3 1680 MG Powder for Oral Suspension	SY	6f8452f8-8c2c-6700-a11d-1531023056c5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
75907-237-14	75907023714	14 PACKET in 1 CARTON (75907-237-14) / 1 POWDER, FOR SUSPENSION in 1 PACKET	14 packet	2024-12-15	No	No	Current
75907-237-42	75907023742	42 PACKET in 1 CARTON (75907-237-42) / 1 POWDER, FOR SUSPENSION in 1 PACKET	42 packet	2025-03-03	No	No	Current