Carvedilol
- Product NDC
- 55111-253
- 11-digit product format
- 551110253
- Labeler code
- 55111
- Product ID
- 55111-253_31305b0b-ee75-85e9-081c-73d15c0a7b83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA076649
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Substance
- CARVEDILOL
- Active strength
- 6.25 mg/1
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carvedilol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARVEDILOL | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K47UL67F2 |
| Rxcui | 200031, 200032, 200033, 686924 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-253-01 | Carvedilol | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 55111-253-05 | Carvedilol | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
| 55111-253-10 | Carvedilol | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 8 |
| 55111-253-30 | Carvedilol | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 55111-253-78 | Carvedilol | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 8 |
| 55111-253-79 | Carvedilol | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] | 13 | |
| Carvedilol | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| Carvedilol | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| colloidal silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| Carvedilol | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-253 | CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 8 | Current NDC, Legacy NDC, 6 package rows | 20190312_1e453c21-a8a8-dc54-5591-74c972d41727.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55111-253-01 | 55111025301 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-253-01) | | 2007-09-05 | 0000-00-00 | No | No | Current |
| 55111-253-05 | 55111025305 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-253-05) | | 2007-09-05 | 0000-00-00 | No | No | Current |
| 55111-253-10 | 55111025310 | 1000 TABLET, FILM COATED in 1 BOTTLE (55111-253-10) | | 2007-09-05 | 0000-00-00 | No | No | Current |
| 55111-253-30 | 55111025330 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-253-30) | | 2007-09-05 | 0000-00-00 | No | No | Current |
| 55111-253-78 | 55111025378 | 10 BLISTER PACK in 1 CARTON (55111-253-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-253-79) | 10 blister pack | 2007-09-05 | 0000-00-00 | No | No | Current |
| 55111-253-79 | 55111025379 | 10 in 1 BLISTER PACK | | | | | | Historical |