CODEINUM
- Product NDC
- 10191-1035
- 11-digit product format
- 101911035
- Labeler code
- 10191
- Product ID
- 10191-1035_1b04bb5f-aaa5-12ed-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CODEINE
- Dosage form
- PELLET
- Route
- SUBLINGUAL
- Labeler
- Remedy Makers
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2015-07-14
- Marketing end
- 0000-00-00
- Substance
- CODEINE ANHYDROUS
- Active strength
- 9 [hp_X]/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 09d8330d-4fec-be98-3a66-f985140646b2 | Product name | 2 | 20210513 |
| 20c8cafe-5cfc-44f8-a9be-a664f437f780 | Product name | 2 | 20200225 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| e9576821-a971-5261-628e-82ad9e10acdb | Product name | 2 | 20150121 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 47fd879b-91c5-e1e5-130f-29d082a871ec | Product name | 1 | 20140508 |
| c35d1ac8-8885-2ee1-6c52-5a715b242c00 | Product name | 1 | 20140508 |
| ce055423-1d7f-3c41-dff1-83660fa8cd96 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10191-1035-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-9efb-f424-e053-dadaa90a57ce | 1b04bb5f-aaa4-12ed-e054-00144ff8d46c |
| 10191-1035-2 | 2023-03-07 | C162847 | 48780-1 | 9d75b9d0-9efb-f424-e053-dadaa90a57ce | 1b04bb5f-aaa4-12ed-e054-00144ff8d46c |
| 10191-1035-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9efb-f424-e053-dadaa90a57ce | 1b04bb5f-aaa4-12ed-e054-00144ff8d46c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10191-1035-2 | CODEINUM | 170 in 1 VIAL, GLASS | PELLET | 170 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CODEINE ANHYDROUS | ACTIVE INGREDIENT | UX6OWY2V7J | CODEINUM (CODEINE) PELLET [REMEDY MAKERS] | 1 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | CODEINUM (CODEINE) PELLET [REMEDY MAKERS] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | CODEINUM (CODEINE) PELLET [REMEDY MAKERS] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CODEINUM (CODEINE) PELLET [REMEDY MAKERS] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10191-1035 | CODEINUM (CODEINE) PELLET [REMEDY MAKERS] | 2 | Legacy NDC, 1 package rows | 20230309_1b04bb5f-aaa4-12ed-e054-00144ff8d46c.zip |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10191-1035-2 | 10191103502 | 170 in 1 VIAL, GLASS | Historical |