FDA.reportPublic FDA data

38779-1935

Product NDC
38779-1935
11-digit product format
387791935
Labeler code
38779
Product ID
38779-1935_43fa3055-27fe-2aa7-e063-6394a90a5ee5
Type
BULK INGREDIENT
Nonproprietary name
Omeprazole
Dosage form
POWDER
Marketing category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Marketing start
2015-07-06
Substance
OMEPRAZOLE
Active strength
1 g/g
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct38779-1935UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-193538779-1935-0UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-193538779-1935-1UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-193538779-1935-2UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-193538779-1935-3UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-193538779-1935-4UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-193538779-1935-5UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-193538779-1935-6UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-193538779-1935-7UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-193538779-1935-8UNFINISHEDActive or certified unfinished drug listing2026-10-16
unfinished packagepackage38779-193538779-1935-9UNFINISHEDActive or certified unfinished drug listing2026-10-16

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 4 · 231 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-1935-4a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-1935-5a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-1935-2a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-1935-7a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-1935-3a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-1935-6a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-1935-9a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-1935-0a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-1935-1a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage38779-1935-8a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-1935-21d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-1935-71d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-1935-11d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-1935-51d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-1935-91d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-1935-41d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-1935-01d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-1935-61d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-1935-81d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage38779-1935-31d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-1935-2390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-1935-7390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-1935-1390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-1935-5390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-1935-9390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-1935-4390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-1935-0390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-1935-6390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-1935-8390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage38779-1935-3390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-1935-2e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-1935-7e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-1935-1e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-1935-5e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-1935-9e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-1935-4e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-1935-0e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-1935-6e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-1935-8e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage38779-1935-3e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-1935-2bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-1935-7bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-1935-1bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-1935-5bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-1935-9bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-1935-4bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-1935-0bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-1935-6bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-1935-8bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage38779-1935-3bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-1935-2f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-1935-7f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-1935-1f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage38779-1935-5f268b84574a6…26285f5ac5df…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE1 g/g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
38779-1935-0GM - Gram38779-1935314d978f-63c6-45c6-b0a8-6de0d967877f12014-09-03
38779-1935-1GM - Gram38779-1935392bffb2-f53b-4cf6-b3bc-f738876273d812018-09-05
38779-1935-2GM - Gram38779-193590311108-78bd-43b7-88d0-b163f53af4ae12019-01-24
38779-1935-3GM - Gram38779-193549e88bd1-9137-43fd-ba97-131f3b3ead4112013-02-19
38779-1935-4GM - Gram38779-193571786d7f-9200-4c1d-9ed5-5984cd467a4612013-02-19
38779-1935-5GM - Gram38779-19353cb2e6dc-c845-4794-b2a5-5db965892f3712013-02-19
38779-1935-6GM - Gram38779-1935d68855f1-f5a5-4359-b285-d726dd05a23c12018-09-05
38779-1935-7GM - Gram38779-1935c1dc8259-8a8b-4804-a0d5-7dee97d6e1ce12014-09-03
38779-1935-8GM - Gram38779-19352646549e-3b2c-4f9c-b7ec-07023b6ed01412013-02-19
38779-1935-9GM - Gram38779-19352737aedd-21bb-4c4e-af65-fa0f3da99cf012013-02-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
38779-1935-03877919350010000 g in 1 DRUM (38779-1935-0)10000 g06-OCT-17Current
38779-1935-138779193501.12 g in 1 BOTTLE (38779-1935-1)06-JUL-15Current
38779-1935-23877919350220000 g in 1 DRUM (38779-1935-2)20000 g06-JUL-15Current
38779-1935-3387791935035 g in 1 VIAL (38779-1935-3)5 g06-OCT-17Current
38779-1935-43877919350425 g in 1 JAR (38779-1935-4)25 g06-OCT-17Current
38779-1935-538779193505100 g in 1 JAR (38779-1935-5)100 g06-OCT-17Current
38779-1935-638779193506.2 g in 1 BOTTLE (38779-1935-6)06-JUL-15Current
38779-1935-73877919350725000 g in 1 DRUM (38779-1935-7)25000 g06-OCT-17Current
38779-1935-838779193508500 g in 1 JAR (38779-1935-8)500 g06-OCT-17Current
38779-1935-9387791935091000 g in 1 JAR (38779-1935-9)1000 g06-OCT-17Current