Cimetidine
- Product NDC
- 55289-581
- 11-digit product format
- 552890581
- Labeler code
- 55289
- Product ID
- 55289-581_419aec97-c220-0c91-e063-6294a90a67b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cimetidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA074246
- Marketing category
- ANDA
- Marketing start
- 1994-05-17
- Substance
- CIMETIDINE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cimetidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIMETIDINE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 80061L1WGD |
| Rxcui | 197507 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-581-10 | Cimetidine | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 13 |
| 55289-581-20 | Cimetidine | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 13 |
| 55289-581-30 | Cimetidine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 13 |
| 55289-581-60 | Cimetidine | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 13 |
| 55289-581-90 | Cimetidine | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CIMETIDINE | ACTIVE INGREDIENT | 80061L1WGD | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| CIMETIDINE | ACTIVE MOIETY | 80061L1WGD | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| VANILLIN | INACTIVE INGREDIENT | CHI530446X | CIMETIDINE (CIMETIDINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-581 | CIMETIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 12 | Current NDC, Legacy NDC, 5 package rows | 20241012_28fd7158-a617-436a-8f5c-71ffbaafe527.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 |
|---|
| 55289-581-10 | 55289058110 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-10) | 2015-11-02 | 0000-00-00 | No | No | Current |
| 55289-581-20 | 55289058120 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-20) | 2015-11-02 | 0000-00-00 | No | No | Current |
| 55289-581-30 | 55289058130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-30) | 2015-11-02 | 0000-00-00 | No | No | Current |
| 55289-581-60 | 55289058160 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-60) | 2015-11-02 | 0000-00-00 | No | No | Current |
| 55289-581-90 | 55289058190 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-581-90) | 2015-11-02 | 0000-00-00 | No | No | Current |