Duloxetine
- Product NDC
- 68180-297
- 11-digit product format
- 681800297
- Labeler code
- 68180
- Product ID
- 68180-297_7efa28f3-0b15-4e1c-835f-2f1dff37bee8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Duloxetine
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA090694
- Marketing category
- ANDA
- Marketing start
- 2015-05-25
- Substance
- DULOXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Duloxetine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DULOXETINE HYDROCHLORIDE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9044SC542W |
| Rxcui | 596926, 596930, 596934, 616402 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-297-03 | Duloxetine | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 25 |
| 68180-297-06 | Duloxetine | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 25 |
| 68180-297-09 | Duloxetine | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DULOXETINE HYDROCHLORIDE | ACTIVE INGREDIENT | 9044SC542W | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| DULOXETINE | ACTIVE MOIETY | O5TNM5N07U | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) | INACTIVE INGREDIENT | G4U024CQK6 | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-297 | DULOXETINE CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.] | 24 | Current NDC, Legacy NDC, 3 package rows | 20250124_829a4f51-c882-4b64-81f3-abfb03a52ebe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-297-03 | 68180029703 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-297-03) | 2015-05-25 | 0000-00-00 | No | No | Current |
| 68180-297-06 | 68180029706 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-297-06) | 2015-07-15 | 0000-00-00 | No | No | Current |
| 68180-297-09 | 68180029709 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-297-09) | 2015-05-25 | 0000-00-00 | No | No | Current |