Lyrica CR
- Product NDC
- 0071-1026
- 11-digit product format
- 000711026
- Labeler code
- 0071
- Product ID
- 0071-1026_df981020-42d9-41ff-b37d-3ddcbf354a86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Parke-Davis Div of Pfizer Inc
- Application
- NDA209501
- Marketing category
- NDA
- Marketing start
- 2018-01-01
- Marketing end
- 0000-00-00
- Substance
- PREGABALIN
- Active strength
- 83 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 0071-1026 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 0071-1026 | 0071-1026-01 | D | Discontinued by firm | 2026-08-11 |
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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 0071-1026 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0071-1026 | 0071-1026-01 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209501-001 | LYRICA CR | PREGABALIN | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 |
| N209501-002 | LYRICA CR | PREGABALIN | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 |
| N209501-003 | LYRICA CR | PREGABALIN | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N209501-001 | AB |
| N209501-002 | AB |
| N209501-003 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209501-001 | 10022447 | 2026-11-02 | U-2136 | 2018-08-16 | |
| N209501-001 | 10022447 | 2026-11-02 | U-2137 | 2018-08-16 | |
| N209501-001 | 8945620 | 2026-11-02 | U-2136 | Drug product | 2017-11-09 |
| N209501-001 | 8945620 | 2026-11-02 | U-2137 | Drug product | 2017-11-09 |
| N209501-001 | 9144559 | 2026-11-02 | Drug product | 2017-11-09 | |
| N209501-001 | 10022447*PED | 2027-05-02 | Pediatric extension | ||
| N209501-001 | 8945620*PED | 2027-05-02 | Pediatric extension | ||
| N209501-001 | 9144559*PED | 2027-05-02 | Pediatric extension | ||
| N209501-002 | 10022447 | 2026-11-02 | U-2136 | 2018-08-16 | |
| N209501-002 | 10022447 | 2026-11-02 | U-2137 | 2018-08-16 | |
| N209501-002 | 8945620 | 2026-11-02 | U-2136 | Drug product | 2017-11-09 |
| N209501-002 | 8945620 | 2026-11-02 | U-2137 | Drug product | 2017-11-09 |
| N209501-002 | 9144559 | 2026-11-02 | Drug product | 2017-11-09 | |
| N209501-002 | 10022447*PED | 2027-05-02 | Pediatric extension | ||
| N209501-002 | 8945620*PED | 2027-05-02 | Pediatric extension | ||
| N209501-002 | 9144559*PED | 2027-05-02 | Pediatric extension | ||
| N209501-003 | 10022447 | 2026-11-02 | U-2136 | 2018-08-16 | |
| N209501-003 | 10022447 | 2026-11-02 | U-2137 | 2018-08-16 | |
| N209501-003 | 8945620 | 2026-11-02 | U-2136 | Drug product | 2017-11-09 |
| N209501-003 | 8945620 | 2026-11-02 | U-2137 | Drug product | 2017-11-09 |
| N209501-003 | 9144559 | 2026-11-02 | Drug product | 2017-11-09 | |
| N209501-003 | 10022447*PED | 2027-05-02 | Pediatric extension | ||
| N209501-003 | 8945620*PED | 2027-05-02 | Pediatric extension | ||
| N209501-003 | 9144559*PED | 2027-05-02 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209501-002 | LYRICA CR | 165MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209501-003 | LYRICA CR | 330MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2017-10-11 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N209501-001 | LYRICA CR | 82.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2017-10-11 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N209501-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209501-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209501-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209501-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209501-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209501-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209501-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209501-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209501-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209501-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209501-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209501-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209501-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209501-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209501-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209501-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209501-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209501-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209501-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209501-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209501-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209501-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N209501-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209501-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209501-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209501-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209501-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209501-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209501-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209501-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209501-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209501-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209501-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209501-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N209501-001 | AB | 1 | 8072bd15b7f6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N209501-001 | 10022447 | 2026-11-02 | U-2137 | 2018-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-001 | 10022447 | 2026-11-02 | U-2136 | 2018-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-001 | 8945620 | 2026-11-02 | U-2136 | Drug product | 2017-11-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-001 | 8945620 | 2026-11-02 | U-2137 | Drug product | 2017-11-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-001 | 9144559 | 2026-11-02 | Drug product | 2017-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-001 | 10022447*PED | 2027-05-02 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N209501-001 | 8945620*PED | 2027-05-02 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N209501-001 | 9144559*PED | 2027-05-02 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N209501-002 | 10022447 | 2026-11-02 | U-2137 | 2018-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-002 | 10022447 | 2026-11-02 | U-2136 | 2018-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-002 | 8945620 | 2026-11-02 | U-2137 | Drug product | 2017-11-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-002 | 8945620 | 2026-11-02 | U-2136 | Drug product | 2017-11-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-002 | 9144559 | 2026-11-02 | Drug product | 2017-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-002 | 10022447*PED | 2027-05-02 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N209501-002 | 8945620*PED | 2027-05-02 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N209501-002 | 9144559*PED | 2027-05-02 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N209501-003 | 10022447 | 2026-11-02 | U-2137 | 2018-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-003 | 10022447 | 2026-11-02 | U-2136 | 2018-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-003 | 8945620 | 2026-11-02 | U-2137 | Drug product | 2017-11-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-003 | 8945620 | 2026-11-02 | U-2136 | Drug product | 2017-11-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-003 | 9144559 | 2026-11-02 | Drug product | 2017-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209501-003 | 10022447*PED | 2027-05-02 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N209501-003 | 8945620*PED | 2027-05-02 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N209501-003 | 9144559*PED | 2027-05-02 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-001 | 10022447 | 2026-11-02 | U-2137 | 2018-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-001 | 10022447 | 2026-11-02 | U-2136 | 2018-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-001 | 8945620 | 2026-11-02 | U-2136 | Drug product | 2017-11-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-001 | 8945620 | 2026-11-02 | U-2137 | Drug product | 2017-11-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-001 | 9144559 | 2026-11-02 | Drug product | 2017-11-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-001 | 10022447*PED | 2027-05-02 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-001 | 8945620*PED | 2027-05-02 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-001 | 9144559*PED | 2027-05-02 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-002 | 10022447 | 2026-11-02 | U-2137 | 2018-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-002 | 10022447 | 2026-11-02 | U-2136 | 2018-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-002 | 8945620 | 2026-11-02 | U-2137 | Drug product | 2017-11-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-002 | 8945620 | 2026-11-02 | U-2136 | Drug product | 2017-11-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-002 | 9144559 | 2026-11-02 | Drug product | 2017-11-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-002 | 10022447*PED | 2027-05-02 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-002 | 8945620*PED | 2027-05-02 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209501-002 | 9144559*PED | 2027-05-02 | Pediatric extension | 31067a03dcf5… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N209501-001 | NP | 2020-10-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N209501-001 | PED | 2021-04-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N209501-002 | NP | 2020-10-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N209501-002 | PED | 2021-04-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N209501-003 | NP | 2020-10-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N209501-003 | PED | 2021-04-11 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N209501-001 | PED | 2021-04-11 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N209501-002 | PED | 2021-04-11 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N209501-003 | PED | 2021-04-11 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N209501-001 | PED | 2021-04-11 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N209501-002 | PED | 2021-04-11 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N209501-003 | PED | 2021-04-11 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N209501-001 | PED | 2021-04-11 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N209501-002 | PED | 2021-04-11 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N209501-003 | PED | 2021-04-11 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N209501-001 | NP | 2020-10-11 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N209501-001 | PED | 2021-04-11 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N209501-002 | NP | 2020-10-11 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N209501-002 | PED | 2021-04-11 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N209501-003 | NP | 2020-10-11 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N209501-003 | PED | 2021-04-11 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N209501-001 | NP | 2020-10-11 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N209501-001 | PED | 2021-04-11 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N209501-002 | NP | 2020-10-11 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N209501-002 | PED | 2021-04-11 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N209501-003 | NP | 2020-10-11 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N209501-003 | PED | 2021-04-11 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N209501-001 | NP | 2020-10-11 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N209501-001 | PED | 2021-04-11 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N209501-002 | NP | 2020-10-11 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N209501-002 | PED | 2021-04-11 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N209501-003 | NP | 2020-10-11 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N209501-003 | PED | 2021-04-11 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N209501-001 | NP | 2020-10-11 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N209501-001 | PED | 2021-04-11 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N209501-002 | NP | 2020-10-11 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N209501-002 | PED | 2021-04-11 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N209501-003 | NP | 2020-10-11 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N209501-003 | PED | 2021-04-11 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N209501-001 | NP | 2020-10-11 | ea99ee380514… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0071-1026-01 | EA - Each | 0071-1026 | 016c5d33-ec4e-4e1f-8fb8-c9084151a479 | 1 | 2018-02-20 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Lyrica CR | PREGABALIN | Viatris Specialty LLC | f280bbd8-2af2-444a-bd96-e409337ca6dd | 2026-03-12 | Warnings, Adverse reactions | 209501 NDA209501 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0071-1026-01 | 00071102601 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0071-1026-01) | 2018-01-01 | 0000-00-00 | No | No | Current |