Glipizide
- Product NDC
- 10370-745
- 11-digit product format
- 103700745
- Labeler code
- 10370
- Product ID
- 10370-745_dc569df1-efda-489d-b287-36e1a94fe09c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glipizide
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA076159
- Marketing category
- ANDA
- Marketing start
- 2016-12-21
- Marketing end
- 0000-00-00
- Substance
- GLIPIZIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ec4adfb0-aabc-95b9-ad07-5cb8f8533a09 | Product name | 2 | 20250625 |
| b1de1ca9-d9db-4f4b-2103-09e2014d30d5 | Product name | 5 | 20180912 |
| 2dee091b-3b8c-d27a-b1ba-fcb0d32e776a | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10370-745-01 | 2022-10-05 | C162847 | 48780-1 | e4f33bdf-aacb-d8a0-e053-dadaa90a6e4e | e17c5e34-156a-468d-999e-15e503fa1fe6 |
| 10370-745-05 | 2022-10-05 | C162847 | 48780-1 | e4f33bdf-aacb-d8a0-e053-dadaa90a6e4e | e17c5e34-156a-468d-999e-15e503fa1fe6 |
| 10370-745-01 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-aacb-d8a0-e053-dadaa90a6e4e | e17c5e34-156a-468d-999e-15e503fa1fe6 |
| 10370-745-05 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-aacb-d8a0-e053-dadaa90a6e4e | e17c5e34-156a-468d-999e-15e503fa1fe6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10370-745-01 | EA - Each | 10370-745 | d839a055-bac6-4dd5-9a57-3c463621704e | 1 | 2017-03-06 |
| 10370-745-05 | EA - Each | 10370-745 | 7097a224-adf2-4210-bb95-4677aacf0015 | 1 | 2017-06-15 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 315107 | glipiZIDE 10 MG 24HR Extended Release Oral Tablet | PSN | 98591ff5-b735-47b0-9bd2-1e9118d261e6 | 10 |
| 314006 | glipiZIDE 5 MG 24HR Extended Release Oral Tablet | PSN | 98591ff5-b735-47b0-9bd2-1e9118d261e6 | 10 |
| 315107 | 24 HR glipizide 10 MG Extended Release Oral Tablet | SCD | 98591ff5-b735-47b0-9bd2-1e9118d261e6 | 10 |
| 314006 | 24 HR glipizide 5 MG Extended Release Oral Tablet | SCD | 98591ff5-b735-47b0-9bd2-1e9118d261e6 | 10 |
| 315107 | glipizide ER 10 MG 24 HR Extended Release Oral Tablet | SY | 98591ff5-b735-47b0-9bd2-1e9118d261e6 | 10 |
| 314006 | glipizide ER 5 MG 24 HR Extended Release Oral Tablet | SY | 98591ff5-b735-47b0-9bd2-1e9118d261e6 | 10 |
| 315107 | glipizide XL 10 MG 24 HR Extended Release Oral Tablet | SY | 98591ff5-b735-47b0-9bd2-1e9118d261e6 | 10 |
| 314006 | glipizide XL 5 MG 24 HR Extended Release Oral Tablet | SY | 98591ff5-b735-47b0-9bd2-1e9118d261e6 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10370-745-01 | 10370074501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-745-01) | 2017-05-16 | 0000-00-00 | No | No | Current |
| 10370-745-05 | 10370074505 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-745-05) | 2017-05-16 | 0000-00-00 | No | No | Current |