Xatmep
- Product NDC
- 52652-2001
- 11-digit product format
- 526522001
- Labeler code
- 52652
- Product ID
- 52652-2001_461e9d94-1451-904d-e063-6294a90a05f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA208400
- Marketing category
- NDA
- Marketing start
- 2017-05-01
- Substance
- METHOTREXATE
- Active strength
- 2.5 mg/mL
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2eb9a854-4fbc-9bbe-3199-41fc1018a1f0 | Product name | 9 | 20250224 |
| 3082de91-569a-4d57-b379-acbf37f1d5c3 | Product name | 1 | 20210312 |
| f76135bc-a210-42d9-851b-1b73cbaccdb3 | Product name | 1 | 20200511 |
| 423544b2-e325-49ee-8910-4c5dfe41906f | Product name | 1 | 20181120 |
| c9fd924b-0a8d-4d53-bf70-11070e24e4dd | Product name | 2 | 20181120 |
| ce1e7cc6-4850-4cb1-8dde-8010b2fbc359 | Product name | 1 | 20181120 |
| eb454f54-2806-4c31-a08b-8dcb08261099 | Product name | 2 | 20181120 |
| d9cebc09-c68d-46f5-bdcd-fd82e945cc27 | Product name | 1 | 20170705 |
| 16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3 | Product name | 2 | 20160504 |
| 88514aea-9d58-4ed2-b135-9811fb14c8fb | Product name | 1 | 20141209 |
| 0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52652-2001-1 | Xatmep | 120 mL in 1 BOTTLE | SOLUTION | 120 | 12 | |
| 52652-2001-6 | Xatmep | 60 mL in 1 BOTTLE | SOLUTION | 60 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52652-2001-1 | ML - Milliliter | 52652-2001 | 81947cdc-1949-45eb-9c27-139d1e2de7c9 | 1 | 2017-06-15 |
| 52652-2001-6 | ML - Milliliter | 52652-2001 | 9ca24a30-63b6-490f-9a6b-f058e76c9c46 | 1 | 2018-09-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52652-2001 | XATMEP (METHOTREXATE) SOLUTION [AZURITY PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20220630_aec9984e-34c5-481b-b6bf-9bb5caf1daf8.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1921592 | methotrexate 2.5 MG/mL Oral Solution | PSN | aec9984e-34c5-481b-b6bf-9bb5caf1daf8 | 12 |
| 1921598 | Xatmep 2.5 MG/mL Oral Solution | PSN | aec9984e-34c5-481b-b6bf-9bb5caf1daf8 | 12 |
| 1921598 | methotrexate 2.5 MG/ML Oral Solution [Xatmep] | SBD | aec9984e-34c5-481b-b6bf-9bb5caf1daf8 | 12 |
| 1921592 | methotrexate 2.5 MG/ML Oral Solution | SCD | aec9984e-34c5-481b-b6bf-9bb5caf1daf8 | 12 |
| 1921592 | methotrexate 2.5 MG/ML (methotrexate sodium 2.74 MG/ML) Oral Solution | SY | aec9984e-34c5-481b-b6bf-9bb5caf1daf8 | 12 |
| 1921598 | methotrexate 2.5 MG/ML (methotrexate sodium 2.74 MG/ML) Oral Solution [Xatmep] | SY | aec9984e-34c5-481b-b6bf-9bb5caf1daf8 | 12 |
| 1921598 | Xatmep 2.5 MG/ML Oral Solution | SY | aec9984e-34c5-481b-b6bf-9bb5caf1daf8 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52652-2001-1 | 52652200101 | 120 mL in 1 BOTTLE (52652-2001-1) | 120 ml | 2017-05-01 | 0000-00-00 | No | No | Current |
| 52652-2001-6 | 52652200106 | 60 mL in 1 BOTTLE (52652-2001-6) | 60 ml | 2018-08-13 | 0000-00-00 | No | No | Current |