KOMBIGLYZE
- Product NDC
- 0310-6145
- 11-digit product format
- 003106145
- Labeler code
- 0310
- Product ID
- 0310-6145_f2b2e5cb-8544-4aae-a3b6-96c8517dab61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA200678
- Marketing category
- NDA
- Marketing start
- 2014-12-04
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
- Active strength
- 1000 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0310-6145 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 0310-6145 | 0310-6145-30 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 0310-6145 | 0310-6145-95 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N200678-001 | KOMBIGLYZE XR | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | |
| N200678-002 | KOMBIGLYZE XR | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | |
| N200678-003 | KOMBIGLYZE XR | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N200678-001 | M-14 | 2027-10-11 |
| N200678-002 | M-14 | 2027-10-11 |
| N200678-003 | M-14 | 2027-10-11 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200678-002 | KOMBIGLYZE XR | 1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200678-003 | KOMBIGLYZE XR | 1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200678-001 | KOMBIGLYZE XR | 500MG;EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2010-11-05 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N200678-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N200678-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N200678-003 | AB | 1 | 9b2671bbb829… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200678-001 | 8628799 | 2025-07-13 | Drug product | 2014-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200678-001 | 9339472 | 2025-07-13 | Drug product | 2016-05-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200678-002 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200678-002 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200678-003 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200678-003 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200678-001 | 8628799 | 2025-07-13 | Drug product | 2014-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200678-001 | 9339472 | 2025-07-13 | Drug product | 2016-05-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200678-002 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200678-002 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200678-003 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N200678-003 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200678-001 | 8628799 | 2025-07-13 | Drug product | 2014-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200678-001 | 9339472 | 2025-07-13 | Drug product | 2016-05-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200678-002 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200678-002 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200678-003 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200678-003 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200678-001 | 8628799 | 2025-07-13 | Drug product | 2014-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200678-001 | 9339472 | 2025-07-13 | Drug product | 2016-05-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200678-002 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200678-002 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200678-003 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200678-003 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200678-001 | 8628799 | 2025-07-13 | Drug product | 2014-01-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200678-001 | 9339472 | 2025-07-13 | Drug product | 2016-05-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200678-002 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200678-002 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200678-003 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200678-003 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200678-001 | 8628799 | 2025-07-13 | Drug product | 2014-01-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200678-001 | 9339472 | 2025-07-13 | Drug product | 2016-05-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200678-002 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200678-002 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200678-003 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200678-003 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200678-001 | 8628799 | 2025-07-13 | Drug product | 2014-01-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200678-001 | 9339472 | 2025-07-13 | Drug product | 2016-05-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200678-002 | 8628799 | 2025-07-13 | Drug product | 2017-03-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200678-002 | 9339472 | 2025-07-13 | Drug product | 2017-03-22 | 5bbf6a4d5a75… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N200678-001 | M-14 | 2027-10-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N200678-002 | M-14 | 2027-10-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N200678-003 | M-14 | 2027-10-11 | caaa826d4ba7… |
| 2019-12-13 00:20 UTC | 2019-12 | N200678-001 | M-175 | 2019-04-05 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N200678-001 | M-198 | 2020-02-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N200678-002 | M-175 | 2019-04-05 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N200678-002 | M-198 | 2020-02-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N200678-003 | M-175 | 2019-04-05 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N200678-003 | M-198 | 2020-02-27 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N200678-001 | M-198 | 2020-02-27 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N200678-002 | M-198 | 2020-02-27 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N200678-003 | M-198 | 2020-02-27 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N200678-001 | M-198 | 2020-02-27 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N200678-002 | M-198 | 2020-02-27 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N200678-003 | M-198 | 2020-02-27 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N200678-001 | M-175 | 2019-04-05 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N200678-001 | M-198 | 2020-02-27 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N200678-002 | M-175 | 2019-04-05 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N200678-002 | M-198 | 2020-02-27 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N200678-003 | M-175 | 2019-04-05 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N200678-003 | M-198 | 2020-02-27 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N200678-001 | M-175 | 2019-04-05 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N200678-001 | M-198 | 2020-02-27 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N200678-002 | M-175 | 2019-04-05 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N200678-002 | M-198 | 2020-02-27 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N200678-003 | M-175 | 2019-04-05 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N200678-003 | M-198 | 2020-02-27 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N200678-001 | M-175 | 2019-04-05 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N200678-001 | M-198 | 2020-02-27 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N200678-002 | M-175 | 2019-04-05 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N200678-002 | M-198 | 2020-02-27 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N200678-003 | M-175 | 2019-04-05 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N200678-003 | M-198 | 2020-02-27 | ea99ee380514… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200678-001 | M-14 | 2027-10-11 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200678-002 | M-14 | 2027-10-11 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N200678-003 | M-14 | 2027-10-11 | a50c72e98297… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0310-6145-30 | EA - Each | 0310-6145 | 2ec2cce9-6b08-40ce-9f98-b5cc834cd243 | 1 | 2015-02-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0310-6145-30 | 00310614530 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6145-30) | 2014-12-22 | 0000-00-00 | No | No | Current | |
| 0310-6145-95 | 00310614595 | 1 BLISTER PACK in 1 CARTON (0310-6145-95) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2014-12-22 | 0000-00-00 | Yes | No | Current |