Cimetidine
- Product NDC
- 0378-0541
- 11-digit product format
- 003780541
- Labeler code
- 0378
- Product ID
- 0378-0541_14717870-5f24-4002-ada5-1c5a44cc2be9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cimetidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA074246
- Marketing category
- ANDA
- Marketing start
- 1994-05-17
- Substance
- CIMETIDINE
- Active strength
- 800 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 80061L1WGD |
| Rxcui | 197505, 197506, 197507, 197508 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-0541-01 | Cimetidine | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CIMETIDINE | ACTIVE INGREDIENT | 80061L1WGD | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| CIMETIDINE | ACTIVE MOIETY | 80061L1WGD | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| VANILLIN | INACTIVE INGREDIENT | CHI530446X | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0541 | CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20240113_06c0a509-026f-44e0-9975-a94a8de51d43.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 |
|---|
| 0378-0541-01 | 00378054101 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0541-01) | 1994-05-17 | 0000-00-00 | No | No | Current |