Diclofenac Sodium
- Product NDC
- 68387-260
- 11-digit product format
- 683870260
- Labeler code
- 68387
- Product ID
- 68387-260_4b03d85a-0a8d-40e8-b8b1-57184ec19082
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Keltman Pharmaceuticals Inc.
- Application
- ANDA077863
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68387-260-20 | Diclofenac Sodium | 20 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 20 | | 1 |
| 68387-260-30 | Diclofenac Sodium | 30 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 30 | | 1 |
| 68387-260-60 | Diclofenac Sodium | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | | 1 |
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 [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| Diclofenac | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68387-260 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [KELTMAN PHARMACEUTICALS INC.] | 1 | Legacy NDC, 3 package rows | 20100617_eff16712-d4c4-4e7b-bf38-c467de1095f4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68387-260-20 | 68387026020 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 68387-260-30 | 68387026030 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 68387-260-60 | 68387026060 | 60 in 1 BOTTLE, PLASTIC | Historical |