Diclofenac Sodium
- Product NDC
- 35356-725
- 11-digit product format
- 353560725
- Labeler code
- 35356
- Product ID
- 35356-725_9486cfe7-5e5e-46ef-aec5-80adc6fa3277
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA090066
- Marketing category
- ANDA
- Marketing start
- 2010-12-31
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 50 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35356-725-30 | Diclofenac Sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 3981 |
| 35356-725-60 | Diclofenac Sodium | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 3981 |
| 35356-725-90 | Diclofenac Sodium | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 3981 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Diclofenac Sodium | ACTIVE INGREDIENT | QTG126297Q | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| DICLOFENAC | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| Titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3965 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35356-725 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [QUALITY CARE PRODUCTS LLC] | 3981 | Legacy NDC, 3 package rows | 20241213_bfa8cb40-3528-4d41-ae77-444e521e30c0.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 |
|---|
| 35356-725-30 | 35356072530 | 30 in 1 BOTTLE | | | | | Historical |
| 35356-725-60 | 35356072560 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (35356-725-60) | 2013-02-07 | 0000-00-00 | No | No | Current |
| 35356-725-90 | 35356072590 | 90 in 1 BOTTLE | | | | | Historical |