Esomeprazole
- Product NDC
- 69618-056
- 11-digit product format
- 696180056
- Labeler code
- 69618
- Product ID
- 69618-056_c928000b-a4cf-6fb0-e053-2995a90a7eef
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esomeprazole
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Reliable 1 Laboratories
- Application
- ANDA207673
- Marketing category
- ANDA
- Marketing start
- 2018-11-01
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM
- Active strength
- 20 mg/1
- 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 |
|---|---|---|---|
| d7006a36-e68d-42e2-8cd3-d725cb2e47b1 | Product name | 6 | 20251027 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 9 | 20180628 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d71865e8-5c35-4d76-8ecd-a7adda982240 | Product name | 8 | 20171212 |
| 094c6751-235c-4d12-acee-2baf94f676f4 | Product name | 1 | 20151116 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69618-056-42 | 2023-01-30 | C162847 | 48780-1 | c7ccaba7-127b-fd44-e053-dadaa90aa01b | Reliable-1 Esomeprazole Magnesium DR Capsules |
| 69618-056-42 | 2021-08-09 | C162847 | 48780-1 | c7ccaba7-127b-fd44-e053-dadaa90aa01b | Reliable-1 Esomeprazole Magnesium DR Capsules |
| 69618-056-42 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-127b-fd44-e053-dadaa90aa01b | Reliable-1 Esomeprazole Magnesium DR Capsules |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69618-056-14 | Esomeprazole | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | 2 | |
| 69618-056-42 | Esomeprazole | 3 in 1 CARTON | CAPSULE | 3 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69618-056-14 | EA - Each | 69618-056 | 6ff2d3b4-243d-41a7-b1d5-7391cc69cfea | 1 | 2019-01-24 |
| 69618-056-42 | EA - Each | 69618-056 | fae021f5-ade7-42ec-836a-1a04495216e9 | 1 | 2019-01-24 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 606726 | esomeprazole magnesium 20 MG Delayed Release Oral Capsule | PSN | 7a7b80f1-fd8a-a78f-e053-2991aa0a7098 | 2 |
| 606726 | esomeprazole 20 MG Delayed Release Oral Capsule | SCD | 7a7b80f1-fd8a-a78f-e053-2991aa0a7098 | 2 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule | SY | 7a7b80f1-fd8a-a78f-e053-2991aa0a7098 | 2 |
| 606726 | esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule | SY | 7a7b80f1-fd8a-a78f-e053-2991aa0a7098 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69618-056-14 | 69618005614 | 14 in 1 BOTTLE, PLASTIC | Historical | ||||
| 69618-056-42 | 69618005642 | 3 BOTTLE, PLASTIC in 1 CARTON (69618-056-42) > 14 CAPSULE in 1 BOTTLE, PLASTIC (69618-056-14) | 2018-11-01 | 0000-00-00 | No | No | Current |