Diclofenac Sodium
- Product NDC
- 43353-784
- 11-digit product format
- 433530784
- Labeler code
- 43353
- Product ID
- 43353-784_fd5924d8-e3f8-4164-81d6-2a5aea0dd202
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, Inc.
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 1998-11-13
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 50 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 |
|---|
| 43353-784-53 | 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 [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| Diclofenac | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| Ferrosoferric Oxide | INACTIVE INGREDIENT | XM0M87F357 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| Shellac | INACTIVE INGREDIENT | 46N107B71O | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| Sodium Starch Glycolate Type A Potato | INACTIVE INGREDIENT | 5856J3G2A2 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| Titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
| Triethyl Citrate | INACTIVE INGREDIENT | 8Z96QXD6UM | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-784 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] | 1 | Legacy NDC, 1 package rows | 20120709_0c4281ab-1cd8-4e45-904c-9b9f5940c3bb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-784-53 | 43353078453 | 60 in 1 BOTTLE, PLASTIC | Historical |