Cymbalta
- Product NDC
- 0002-3235
- Requested package NDC
- 0002-3235-60
- 11-digit product format
- 000023235
- Labeler code
- 0002
- Product ID
- 0002-3235_aa5061b1-f237-425a-9d05-575c333dfd37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine hydrochloride
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Eli Lilly and Company
- Application
- NDA021427
- Marketing category
- NDA
- Marketing start
- 2004-08-24
- Marketing end
- 2026-10-02
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021427-001 | CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | RLD | 2004-08-03 | |
| N021427-002 | CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | RLD | 2004-08-03 | |
| N021427-004 | CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | RLD | 2004-08-03 |
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 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | RLD | 2004-08-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | RLD | 2004-08-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | RLD | 2004-08-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | RLD | 2004-08-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | RLD | 2004-08-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | RLD | 2004-08-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021427-002 | CYMBALTA | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021427-004 | CYMBALTA | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD, RS | 2004-08-03 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021427-001 | CYMBALTA | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RLD | 2004-08-03 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | N021427-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021427-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021427-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021427-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021427-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021427-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021427-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021427-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021427-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021427-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021427-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021427-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021427-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021427-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021427-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021427-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021427-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021427-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021427-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021427-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021427-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021427-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021427-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021427-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021427-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021427-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021427-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021427-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021427-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021427-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021427-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021427-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021427-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021427-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021427-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021427-004 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021427-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021427-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021427-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021427-001 | AB | 1 | 5d02ea3f76ae… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021427-001 | 6596756 | 2019-09-10 | U-882 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021427-001 | 6596756*PED | 2020-03-10 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021427-002 | 6596756 | 2019-09-10 | U-882 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021427-002 | 6596756*PED | 2020-03-10 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021427-004 | 6596756 | 2019-09-10 | U-882 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021427-004 | 6596756*PED | 2020-03-10 | Pediatric extension | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021427-001 | 6596756*PED | 2020-03-10 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021427-002 | 6596756*PED | 2020-03-10 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021427-004 | 6596756*PED | 2020-03-10 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021427-001 | 6596756*PED | 2020-03-10 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021427-002 | 6596756*PED | 2020-03-10 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021427-004 | 6596756*PED | 2020-03-10 | Pediatric extension | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021427-001 | 6596756 | 2019-09-10 | U-882 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021427-001 | 6596756*PED | 2020-03-10 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021427-002 | 6596756 | 2019-09-10 | U-882 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021427-002 | 6596756*PED | 2020-03-10 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021427-004 | 6596756 | 2019-09-10 | U-882 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021427-004 | 6596756*PED | 2020-03-10 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021427-001 | 6596756 | 2019-09-10 | U-882 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021427-001 | 6596756*PED | 2020-03-10 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021427-002 | 6596756 | 2019-09-10 | U-882 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021427-002 | 6596756*PED | 2020-03-10 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021427-004 | 6596756 | 2019-09-10 | U-882 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021427-004 | 6596756*PED | 2020-03-10 | Pediatric extension | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021427-001 | 6596756 | 2019-09-10 | U-882 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021427-001 | 6596756*PED | 2020-03-10 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021427-002 | 6596756 | 2019-09-10 | U-882 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021427-002 | 6596756*PED | 2020-03-10 | Pediatric extension | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021427-004 | 6596756 | 2019-09-10 | U-882 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021427-004 | 6596756*PED | 2020-03-10 | Pediatric extension | ea99ee380514… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021427-001 | NPP | 2023-04-20 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021427-002 | NPP | 2023-04-20 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021427-004 | NPP | 2023-04-20 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021427-001 | NPP | 2023-04-20 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021427-002 | NPP | 2023-04-20 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021427-004 | NPP | 2023-04-20 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021427-001 | NPP | 2023-04-20 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021427-002 | NPP | 2023-04-20 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021427-004 | NPP | 2023-04-20 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N021427-001 | NPP | 2023-04-20 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021427-002 | NPP | 2023-04-20 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021427-004 | NPP | 2023-04-20 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021427-001 | NPP | 2023-04-20 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021427-002 | NPP | 2023-04-20 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021427-004 | NPP | 2023-04-20 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021427-001 | NPP | 2023-04-20 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021427-002 | NPP | 2023-04-20 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021427-004 | NPP | 2023-04-20 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021427-001 | NPP | 2023-04-20 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021427-002 | NPP | 2023-04-20 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021427-004 | NPP | 2023-04-20 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021427-001 | NPP | 2023-04-20 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021427-002 | NPP | 2023-04-20 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021427-004 | NPP | 2023-04-20 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021427-001 | NPP | 2023-04-20 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021427-002 | NPP | 2023-04-20 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021427-004 | NPP | 2023-04-20 | c0c555d07b60… |
| 2023-12-20 04:57 UTC | 2023-12 | N021427-001 | NPP | 2023-04-20 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N021427-002 | NPP | 2023-04-20 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N021427-004 | NPP | 2023-04-20 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021427-001 | NPP | 2023-04-20 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021427-002 | NPP | 2023-04-20 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021427-004 | NPP | 2023-04-20 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021427-001 | NPP | 2023-04-20 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021427-002 | NPP | 2023-04-20 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021427-004 | NPP | 2023-04-20 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021427-001 | NPP | 2023-04-20 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021427-002 | NPP | 2023-04-20 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021427-004 | NPP | 2023-04-20 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021427-001 | NPP | 2023-04-20 | 3f0d92c62455… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cymbalta
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DULOXETINE HYDROCHLORIDE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9044SC542W | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| aebfdb62-b550-4c4f-9225-d5d3bbc7ab88 | Product name | 9 | 20210727 |
| 7dd29e28-6b69-499b-9257-12a3b46ca283 | Product name | 1 | 20191120 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0002-3235-60 | Cymbalta | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | 90 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0002-3235-60 | EA - Each | 0002-3235 | 4b7893ab-515d-4bee-b8ab-c950ba7fb1d2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Cymbalta | DULOXETINE HYDROCHLORIDE | Eli Lilly and Company | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 2025-07-21 | Boxed warning, Warnings, Adverse reactions | 021427 NDA021427 0002-3235-60 0002-3235 00002323560 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 596928 | Cymbalta 20 MG Delayed Release Oral Capsule | PSN | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596932 | Cymbalta 30 MG Delayed Release Oral Capsule | PSN | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 615186 | Cymbalta 60 MG Delayed Release Oral Capsule | PSN | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596926 | DULoxetine 20 MG Delayed Release Oral Capsule | PSN | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596930 | DULoxetine 30 MG Delayed Release Oral Capsule | PSN | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596934 | DULoxetine 60 MG Delayed Release Oral Capsule | PSN | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596928 | duloxetine 20 MG Delayed Release Oral Capsule [Cymbalta] | SBD | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596932 | duloxetine 30 MG Delayed Release Oral Capsule [Cymbalta] | SBD | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 615186 | duloxetine 60 MG Delayed Release Oral Capsule [Cymbalta] | SBD | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596926 | duloxetine 20 MG Delayed Release Oral Capsule | SCD | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596930 | duloxetine 30 MG Delayed Release Oral Capsule | SCD | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596934 | duloxetine 60 MG Delayed Release Oral Capsule | SCD | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596928 | Cymbalta 20 MG (as duloxetine hydrochloride 22.4 MG) Delayed Release Oral Capsule | SY | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596928 | Cymbalta 20 MG Delayed Release Oral Capsule | SY | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596932 | Cymbalta 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule | SY | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596932 | Cymbalta 30 MG Delayed Release Oral Capsule | SY | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 615186 | Cymbalta 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596926 | duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule | SY | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596930 | duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule | SY | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596934 | duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 90 |
| 596928 | Cymbalta 20 MG Delayed Release Oral Capsule | PSN | 00acd9e9-b26a-4626-949e-112ecd2f27e6 | 3 |
| 596926 | DULoxetine 20 MG Delayed Release Oral Capsule | PSN | 00acd9e9-b26a-4626-949e-112ecd2f27e6 | 3 |
| 596928 | duloxetine 20 MG Delayed Release Oral Capsule [Cymbalta] | SBD | 00acd9e9-b26a-4626-949e-112ecd2f27e6 | 3 |
| 596926 | duloxetine 20 MG Delayed Release Oral Capsule | SCD | 00acd9e9-b26a-4626-949e-112ecd2f27e6 | 3 |
| 596928 | Cymbalta 20 MG (as duloxetine hydrochloride 22.4 MG) Delayed Release Oral Capsule | SY | 00acd9e9-b26a-4626-949e-112ecd2f27e6 | 3 |
| 596928 | Cymbalta 20 MG Delayed Release Oral Capsule | SY | 00acd9e9-b26a-4626-949e-112ecd2f27e6 | 3 |
| 596926 | duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule | SY | 00acd9e9-b26a-4626-949e-112ecd2f27e6 | 3 |
| 596928 | Cymbalta 20 MG Delayed Release Oral Capsule | PSN | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596928 | Cymbalta 20 MG Delayed Release Oral Capsule | PSN | 7db112de-473a-4407-bc1c-35d0ab748700 | 1 |
| 596932 | Cymbalta 30 MG Delayed Release Oral Capsule | PSN | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596932 | Cymbalta 30 MG Delayed Release Oral Capsule | PSN | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 615186 | Cymbalta 60 MG Delayed Release Oral Capsule | PSN | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 615186 | Cymbalta 60 MG Delayed Release Oral Capsule | PSN | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 596926 | DULoxetine 20 MG Delayed Release Oral Capsule | PSN | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596926 | DULoxetine 20 MG Delayed Release Oral Capsule | PSN | 7db112de-473a-4407-bc1c-35d0ab748700 | 1 |
| 596930 | DULoxetine 30 MG Delayed Release Oral Capsule | PSN | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 596930 | DULoxetine 30 MG Delayed Release Oral Capsule | PSN | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596934 | DULoxetine 60 MG Delayed Release Oral Capsule | PSN | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 596934 | DULoxetine 60 MG Delayed Release Oral Capsule | PSN | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596928 | duloxetine 20 MG Delayed Release Oral Capsule [Cymbalta] | SBD | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596928 | duloxetine 20 MG Delayed Release Oral Capsule [Cymbalta] | SBD | 7db112de-473a-4407-bc1c-35d0ab748700 | 1 |
| 596932 | duloxetine 30 MG Delayed Release Oral Capsule [Cymbalta] | SBD | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 596932 | duloxetine 30 MG Delayed Release Oral Capsule [Cymbalta] | SBD | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 615186 | duloxetine 60 MG Delayed Release Oral Capsule [Cymbalta] | SBD | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 615186 | duloxetine 60 MG Delayed Release Oral Capsule [Cymbalta] | SBD | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 596926 | duloxetine 20 MG Delayed Release Oral Capsule | SCD | 7db112de-473a-4407-bc1c-35d0ab748700 | 1 |
| 596926 | duloxetine 20 MG Delayed Release Oral Capsule | SCD | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596930 | duloxetine 30 MG Delayed Release Oral Capsule | SCD | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596930 | duloxetine 30 MG Delayed Release Oral Capsule | SCD | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 596934 | duloxetine 60 MG Delayed Release Oral Capsule | SCD | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596934 | duloxetine 60 MG Delayed Release Oral Capsule | SCD | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 596928 | Cymbalta 20 MG (as duloxetine hydrochloride 22.4 MG) Delayed Release Oral Capsule | SY | 7db112de-473a-4407-bc1c-35d0ab748700 | 1 |
| 596928 | Cymbalta 20 MG (as duloxetine hydrochloride 22.4 MG) Delayed Release Oral Capsule | SY | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596928 | Cymbalta 20 MG Delayed Release Oral Capsule | SY | 7db112de-473a-4407-bc1c-35d0ab748700 | 1 |
| 596928 | Cymbalta 20 MG Delayed Release Oral Capsule | SY | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596932 | Cymbalta 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule | SY | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 596932 | Cymbalta 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule | SY | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596932 | Cymbalta 30 MG Delayed Release Oral Capsule | SY | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596932 | Cymbalta 30 MG Delayed Release Oral Capsule | SY | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 615186 | Cymbalta 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 615186 | Cymbalta 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 596926 | duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule | SY | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596926 | duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule | SY | 7db112de-473a-4407-bc1c-35d0ab748700 | 1 |
| 596930 | duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule | SY | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596930 | duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule | SY | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
| 596934 | duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | 81a06b90-50d3-40c1-98ca-0e344c76b2c4 | 1 |
| 596934 | duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule | SY | 67927928-c20f-4e12-a327-d26561d7810a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0002-3235-60 | 00002323560 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3235-60) | 2004-08-24 | 2026-10-02 | No | No | Current |