Omeprazole, Sodium bicarbonate
- Product NDC
- 69784-700
- 11-digit product format
- 697840700
- Labeler code
- 69784
- Product ID
- 69784-700_fc55b9b7-0dc1-4304-abe0-aa4495e55ada
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole, Sodium bicarbonate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Woodward Pharma Services LLC
- Application
- ANDA212587
- Marketing category
- ANDA
- Marketing start
- 2021-05-11
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE; SODIUM BICARBONATE
- Active strength
- 40 mg/1; mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69784-700-30 | 2025-09-17 | C162847 | 48780-1 | f386c649-f32b-0266-e053-dadaa90a7c1a | 5cb3b887-919f-4c47-aa07-eb10182dfcc3 |
| 69784-700-30 | 2023-01-30 | C162847 | 48780-1 | f386c649-f32b-0266-e053-dadaa90a7c1a | 5cb3b887-919f-4c47-aa07-eb10182dfcc3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69784-700-30 | EA - Each | 69784-700 | 30341105-b34b-4d11-b6d8-76a3efe0693b | 1 | 2021-07-15 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 616541 | omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule | PSN | 8ab39749-8e9f-468b-be9b-bce630dbffde | 103 |
| 616541 | omeprazole 40 MG / sodium bicarbonate 1100 MG Oral Capsule | SCD | 8ab39749-8e9f-468b-be9b-bce630dbffde | 103 |
| 616541 | Omeprazole 40 MG / NaHCO3 1100 MG Oral Capsule | SY | 8ab39749-8e9f-468b-be9b-bce630dbffde | 103 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69784-700-30 | 69784070030 | 30 CAPSULE in 1 BOTTLE (69784-700-30) | 30 capsule | 2021-05-11 | 0000-00-00 | No | No | Current |
| 69784-700-77 | 69784070077 | 30 CAPSULE in 1 BOTTLE (69784-700-77) | 30 capsule | 2021-05-11 | 0000-00-00 | No | No | Current |