JANUVIA
- Product NDC
- 50090-5517
- Requested package NDC
- 50090-5517-0
- 11-digit product format
- 500905517
- Labeler code
- 50090
- Product ID
- 50090-5517_d282a667-04f0-4e97-8d6f-963ee965fe94
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sitagliptin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA021995
- Marketing category
- NDA
- Marketing start
- 2006-10-16
- Marketing end
- 0000-00-00
- Substance
- SITAGLIPTIN PHOSPHATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- 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 package | package | 50090-5517 | 50090-5517-0 | 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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021995-001 | JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 2006-10-16 |
| N021995-002 | JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 2006-10-16 |
| N021995-003 | JANUVIA | SITAGLIPTIN PHOSPHATE | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-10-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021995-001 | AB |
| N021995-002 | AB |
| N021995-003 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021995-001 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | |
| N021995-001 | 7326708*PED | 2027-05-24 | Pediatric extension | ||
| N021995-002 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | |
| N021995-002 | 7326708*PED | 2027-05-24 | Pediatric extension | ||
| N021995-003 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | |
| N021995-003 | 7326708*PED | 2027-05-24 | Pediatric extension |
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 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 2006-10-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 2006-10-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-10-16 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | AB | RLD | 2006-10-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | AB | RLD | 2006-10-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | AB | RLD, RS | 2006-10-16 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021995-002 | JANUVIA | EQ 50MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021995-003 | JANUVIA | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2006-10-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021995-001 | JANUVIA | EQ 25MG BASE | TABLET / ORAL | RLD | 2006-10-16 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021995-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021995-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021995-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021995-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021995-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021995-003 | AB | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021995-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021995-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021995-003 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021995-001 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021995-001 | 7326708*PED | 2027-05-24 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021995-002 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021995-002 | 7326708*PED | 2027-05-24 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021995-003 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021995-003 | 7326708*PED | 2027-05-24 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021995-001 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021995-001 | 7326708*PED | 2027-05-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021995-002 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021995-002 | 7326708*PED | 2027-05-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021995-003 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021995-003 | 7326708*PED | 2027-05-24 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021995-001 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021995-001 | 7326708*PED | 2027-05-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021995-002 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021995-002 | 7326708*PED | 2027-05-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021995-003 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021995-003 | 7326708*PED | 2027-05-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021995-001 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021995-001 | 7326708*PED | 2027-05-24 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021995-002 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021995-002 | 7326708*PED | 2027-05-24 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021995-003 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021995-003 | 7326708*PED | 2027-05-24 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021995-001 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021995-001 | 7326708*PED | 2027-05-24 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021995-002 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021995-002 | 7326708*PED | 2027-05-24 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021995-003 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021995-003 | 7326708*PED | 2027-05-24 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021995-001 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021995-001 | 7326708*PED | 2027-05-24 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021995-002 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021995-002 | 7326708*PED | 2027-05-24 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021995-003 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021995-003 | 7326708*PED | 2027-05-24 | Pediatric extension | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-001 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-001 | 7326708*PED | 2027-05-24 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-002 | 7326708 | 2026-11-24 | U-802 | Drug substance, Drug product | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-002 | 7326708*PED | 2027-05-24 | Pediatric extension | 03ed91905a0d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-001 | M-187 | 2023-12-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-001 | PED | 2024-06-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-002 | M-187 | 2023-12-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-002 | PED | 2024-06-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-003 | M-187 | 2023-12-04 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021995-003 | PED | 2024-06-04 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021995-001 | M-187 | 2023-12-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021995-001 | PED | 2024-06-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021995-002 | M-187 | 2023-12-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021995-002 | PED | 2024-06-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021995-003 | M-187 | 2023-12-04 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021995-003 | PED | 2024-06-04 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021995-001 | M-187 | 2023-12-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021995-001 | PED | 2024-06-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021995-002 | M-187 | 2023-12-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021995-002 | PED | 2024-06-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021995-003 | M-187 | 2023-12-04 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021995-003 | PED | 2024-06-04 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021995-001 | M-187 | 2023-12-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021995-001 | PED | 2024-06-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021995-002 | M-187 | 2023-12-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021995-002 | PED | 2024-06-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021995-003 | M-187 | 2023-12-04 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021995-003 | PED | 2024-06-04 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021995-001 | M-187 | 2023-12-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021995-001 | PED | 2024-06-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021995-002 | M-187 | 2023-12-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021995-002 | PED | 2024-06-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021995-003 | M-187 | 2023-12-04 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021995-003 | PED | 2024-06-04 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021995-001 | M-187 | 2023-12-04 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021995-001 | PED | 2024-06-04 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021995-002 | M-187 | 2023-12-04 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021995-002 | PED | 2024-06-04 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021995-003 | M-187 | 2023-12-04 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021995-003 | PED | 2024-06-04 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021995-001 | M-187 | 2023-12-04 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021995-001 | PED | 2024-06-04 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021995-002 | M-187 | 2023-12-04 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021995-002 | PED | 2024-06-04 | 301d65b070ca… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-5517-0 | EA - Each | 50090-5517 | 49690f19-22d6-4cc7-a18b-f7d35de3e625 | 1 | 2022-04-06 |
| 50090-5517-1 | EA - Each | 50090-5517 | 5de5a6fd-7792-46d2-9382-782d82d23c4b | 1 | 2022-12-07 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| JANUVIA | SITAGLIPTIN | A-S Medication Solutions | 62c4f58b-2b28-4825-aeb6-213ab9b7a026 | 2026-07-08 | Warnings, Adverse reactions | 021995 NDA021995 |
| JANUVIA | SITAGLIPTIN | A-S Medication Solutions | 194c3718-5eb5-4cf5-85d0-2bb1ed8293b8 | 2026-07-08 | Warnings, Adverse reactions | 021995 NDA021995 |
| JANUVIA | SITAGLIPTIN | A-S Medication Solutions | 4a758211-8af1-449b-9a10-f3d67d7ec8b6 | 2026-07-08 | Warnings, Adverse reactions | 021995 NDA021995 |
| JANUVIA | SITAGLIPTIN | A-S Medication Solutions | 1b03c82f-b52e-4092-b9dc-f2c9b0d6ab40 | 2026-07-08 | Warnings, Adverse reactions | 021995 NDA021995 |
| JANUVIA | SITAGLIPTIN | A-S Medication Solutions | eb81a45f-05b8-49de-99ce-5089bd360d9b | 2026-07-08 | Warnings, Adverse reactions | 021995 NDA021995 |
| JANUVIA | SITAGLIPTIN | Cardinal Health 107, LLC | 9d558f96-24a5-4788-8933-38256c17384b | 2025-11-05 | Warnings, Adverse reactions | 021995 NDA021995 |
| JANUVIA | SITAGLIPTIN | Cardinal Health 107, LLC | 39253ddd-0245-43b1-ad28-d5923983afb4 | 2025-11-05 | Warnings, Adverse reactions | 021995 NDA021995 |
| JANUVIA | SITAGLIPTIN | Merck Sharp & Dohme LLC | f85a48d0-0407-4c50-b0fa-7673a160bf01 | 2024-11-14 | Warnings, Adverse reactions | 021995 NDA021995 |
| JANUVIA | SITAGLIPTIN | A-S Medication Solutions | e2e576e6-6181-4178-b989-61d0e795e559 | 2024-01-31 | Warnings, Adverse reactions | 021995 NDA021995 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-5517-0 | 50090551700 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5517-0) | 2021-04-13 | 0000-00-00 | No | No | Current |